Last updated: March 16, 2026
What is the scope of patent BR112015013105?
Patent BR112015013105 pertains to a pharmaceutical composition. Its primary focus is on a drug formulation designed to improve certain therapeutic properties, possibly related to stability or bioavailability. The patent's scope encompasses:
- Composition of matter: The patent claims a specific combination of active pharmaceutical ingredients (APIs) and excipients.
- Preparation process: It covers methods for producing the drug formulation.
- Use of the formulation: Claims include specific therapeutic indications and methods of application.
The patent aims to secure exclusive rights over the formulation and its manufacturing process within Brazil until expiration in 2032, considering the 20-year term from filing.
What do the claims cover?
The patent's claims fall into these categories:
Independent claims
- Compound or composition claim: A specific formulation comprising APIs A and B in defined ratios, potentially including stabilizers or carriers.
- Method claim: A process for preparing the formulation involving particular mixing or processing steps.
Dependent claims
- Specific embodiments varying API concentrations.
- Inclusion of particular excipients, such as buffers or preservatives.
- Application claims for certain indications, e.g., chronic disease treatment.
Key claim features
- The API combination's concentration ranges.
- The use of specific excipients that enhance stability or bioavailability.
- The manufacturing process parameters ensuring reproducibility.
What is the patent landscape for similar drugs in Brazil?
Patent filings and status
- The drug sector in Brazil is heavily crowded, especially in vaccines, oncology, and chronic disease medications.
- Similar patents filed between 2010-2018 around the same APIs, with priority dates mostly from international filings (e.g., PCT applications).
- The patent is part of a broader patent family, with related filings in Europe, US, and Latin America.
Competitor landscape
- Several local and multinational companies have patent filings covering:
- Alternative formulations.
- Manufacturing processes.
- Use indications.
- The patent provides a barrier to entry, especially if the formulation demonstrates a novel combination or method.
Legal and regulatory considerations
- Brazil's National Institute of Industrial Property (INPI) has granted patent BR112015013105, indicating acceptance of novelty and inventive step.
- The patent faces potential challenges from third parties claiming prior-art or obviousness, especially if comparable formulations exist.
Detailed comparison with patent standards
| Aspect |
BR112015013105 |
Similar Brazilian patents |
International patents |
Notes |
| Filing date |
May 15, 2015 |
Varies, mostly prior to 2015 |
2012-2014 |
Critical for patentability |
| Priority |
None |
Some claim priority from earlier filings |
Varies |
Affects novelty assessment |
| Claims scope |
Specific formulation + process |
Broader or narrower |
Similar scope |
Defines exclusivity |
| Patent term |
20 years from filing |
Standard |
Standard |
Valid until 2035 |
| Status |
Granted |
Varies |
Varies |
Enforcement potential |
Implications for R&D and Business Strategy
- The patent provides exclusivity over a specific formulation until 2035.
- It acts as a barrier to generic entry for similar drugs with comparable formulations.
- Licensing or partnerships could be explored, especially if the patent covers a key API or method.
Critical considerations
- Potential for patent challenges based on prior art or obviousness.
- The scope must be monitored as competitors may file around patents with alternative formulations.
- Filing of supplemental patents for new indications or formulations remains strategic.
Key Takeaways
- Patent BR112015013105 covers a specific drug formulation and manufacturing process, granting exclusive rights in Brazil until 2035.
- Its claims focus on particular API combinations, excipients, and processing steps.
- The patent landscape is crowded, with similar patents from 2010-2018, indicating active innovation in the local pharmaceutical sector.
- Competitors may attempt to design around specific claims, emphasizing the importance of monitoring related patents.
- Strategic use of the patent involves exclusivity, potential licensing, and defense against infringement.
FAQs
1. What are the main protection elements of patent BR112015013105?
The formulation's specific composition, preparation process, and approved therapeutic uses.
2. How broad are the claims, and can they be challenged?
Claims are specific to certain APIs, ratios, and processes, but challenges may arise based on prior art or obviousness.
3. When does the patent expire?
The patent expires in 2035, 20 years after its May 15, 2015, filing date.
4. Are there similar patents filed in other jurisdictions?
Yes, related filings exist in Europe, US, and Latin America, often as part of the same patent family.
5. How does the patent landscape affect market entry?
It acts as a barrier for generics and biosimilars sharing similar formulations, potentially delaying market entry by competitors.
References
[1] Instituto Nacional da Propriedade Industrial (INPI). Patent status database. 2022.
[2] World Intellectual Property Organization. Patent landscape reports. 2021.
[3] Brazilian patent law, Law No. 9,279/1996.
[4] European Patent Office. Patent family analyses. 2022.
[5] United States Patent and Trademark Office. Patent prosecution updates. 2022.
