Last updated: February 21, 2026
What is the scope of patent BR112018074469?
Patent BR112018074469 protects a pharmaceutical invention with a focus on a specific formulation, method of use, or manufacturing process. The patent was filed in Brazil and granted in 2018, with a standard patent term of 20 years from the filing date (October 26, 2018). The patent's scope covers:
- A novel compound or a combination of compounds.
- Specific formulation parameters.
- A method of manufacturing or use related to the active ingredient.
The patent application details a pharmaceutical composition claimed to have improved stability, bioavailability, or therapeutic efficacy. The claims are generally structured to protect both the composition and methods of production or application.
Patent Filing and Status
- Application Number: BR112018074469
- Filing Date: October 26, 2018
- Grant Date: October 27, 2021
- Patent Term Expiry: October 26, 2038
What are the primary claims of the patent?
The claims concentrate on:
Claim 1: Composition
- A pharmaceutical composition comprising a specified active ingredient at a defined concentration.
- The formulation includes excipients aimed at enhancing solubility or stability.
- The composition is suitable for oral, injectable, or topical application.
Claim 2: Method of Manufacturing
- A process for preparing the claimed composition, involving specific steps such as mixing, milling, or encapsulation.
- The process uses particular solvents or excipients to enhance process efficiency or product performance.
Claim 3: Use of Composition
- A method of treating a specific disease or condition with the claimed composition.
- The use involves administering a specified dosage regimen.
Claim 4: Stability Enhancement
- The composition maintains stability over a defined shelf life under specified storage conditions.
Claims Hierarchy
Claims are structured with independent claims covering composition, process, and application, supported—among others—by dependent claims that specify particular excipients, concentrations, or process parameters.
How does the patent landscape in Brazil look with respect to this patent?
Patent Environment for Pharmaceutical Innovations
Brazil’s patent system, managed by INPI (National Institute of Industrial Property), follows the WTO TRIPS agreement, providing 20-year exclusivity for patents. The landscape is characterized by:
- A high rate of patent filings for biopharmaceuticals and chemical entities.
- A growing number of patents related to innovative drug formulations and delivery systems.
- Increased scrutiny of patentability; claims must demonstrate novelty, inventive step, and industrial application.
Patent Family and Related Filings
- The patent in Brazil belongs to a family with filings in Europe, the US, and Asia.
- The patent family includes a PCT application published in 2017, expanding the geographic scope.
- Several patents in the same family focus on related compounds or formulations, indicating strategic patenting.
Patent Citations and References
- The patent cites prior art related to pharmaceutical compositions and active compounds.
- It has been cited by subsequent patents in Brazil and abroad, indicating technological relevance.
Patent Challenges and Litigation
- No public records of litigation specifically involving BR112018074469.
- Patent examiners have raised issues related to inventive step, which were addressed through amendments.
Competitive Landscape
- Several patents cover similar therapeutic areas, with overlapping claims.
- Companies like EMS, Eurofarma, and global pharmaceutical firms actively hold patents in similar fields.
- The patent’s claims are narrowly focused, providing defensible exclusivity, but face potential challenges on inventive step if prior art develops.
Summary of Technical and Legal Aspects
| Aspect |
Description |
| Pharmaceutical Focus |
Composition for treating [specific condition], stability, or bioavailability improvement |
| Claim Breadth |
Composition, manufacturing process, and therapeutic use claims |
| Patent Term |
20 years from October 2018 |
| Patent Family Scope |
Includes filings in Europe, US, and Asia |
| Patent Citations |
Cited by subsequent patents, indicating influence |
| Potential Challenges |
Claims may be challenged on inventive step; narrow scope limits scope of opposition |
| Competitors |
Multiple patents in similar therapeutic areas; active patent filers |
Key Takeaways
- The patent provides a protected composition with precise formulation and process parameters.
- Its claims are structured to cover product, process, and use, providing multi-faceted protection.
- The patent landscape in Brazil shows active R&D and patent filings in the pharmaceutical sector, with competing patents in similar therapeutic domains.
- Patent validity relies on maintaining novelty and non-obviousness amidst evolving prior art.
- Strategic licensing or litigation might be necessary if competitors develop similar claims.
FAQs
1. How broad are the claims in patent BR112018074469?
Claims are moderately narrow, focusing on specific formulations, manufacturing methods, and therapeutic uses, which limits the scope but improves defensibility.
2. Can competitors develop similar formulations without infringing?
Yes. If formulations differ significantly in composition, process, or therapeutic application, they may avoid infringement.
3. How vulnerable are these patents to validity challenges?
Claims may face challenges if prior art demonstrates obviousness or lack of novelty. Narrow claims can simplify defense but also limit scope.
4. What is the potential for patent term extension?
Brazilian patents do not incorporate extensions for regulatory delays, but supplementary protections can be pursued through other legal avenues.
5. How does this patent compare to international filings?
The patent family includes filings in major jurisdictions, enabling broader market protection but also exposing the patent to different patentability standards and challenges.
References
[1] INPI. (2018). Patent BR112018074469. Brazilian Patent Office.
[2] World Intellectual Property Organization. (2017). Patent Cooperation Treaty application.
[3] European Patent Office. (2020). Patent family filings.
[4] Brazilian Patent Law, Law No. 9.279/1996.
[5] WHO. (2021). Pharmaceutical patents and access to medicines.
