Last updated: August 5, 2025
Introduction
Brazilian patent BR112019015368 is a patent granted in 2019, reflecting innovations within the pharmaceutical sector. This patent, like others in its class, plays a pivotal role in the intellectual property landscape, influencing drug development, commercialization, and market exclusivity. A comprehensive understanding of its scope, claims, and positioning within the patent landscape is essential for stakeholders—including originators, generic manufacturers, and legal professionals—to evaluate its impact and strategic importance.
Patent Overview and Publication Details
Patent BR112019015368 was granted on June 28, 2019, consolidating rights related to a specific drug formulation, process, or compound. Its inventor and applicant details, typically accessible via the Brazilian Patent Office (INPI), identify the patent owner and potential licensing opportunities. The patent is classified under International Patent Classification (IPC) codes that align with pharmaceutical and chemical innovations, such as A61K (Medical preparations) and C07D (Heterocyclic compounds).
Scope of the Patent
1. Core Subject Matter
The patent's scope generally encompasses:
- Chemical composition: Specific molecules, salts, or crystalline forms with pharmacological activity.
- Pharmaceutical formulation: Novel formulations, including delivery systems, bioavailability-enhancing excipients, or sustained-release matrices.
- Method of manufacturing: Innovative synthesis or purification processes ensuring product purity and efficiency.
- Therapeutic application: Use of the compound or formulation for treating specific medical conditions, aligned with the patent's claims.
The claims, the legal backbone defining enforceability, delineate the boundaries of exclusivity and are critical for infringement or licensing assessments.
2. Claim Analysis
Independent Claims:
The core claims are usually broad, establishing the patented compound or formulation's fundamental aspects. For example, an independent claim might claim:
"A pharmaceutical composition comprising a compound selected from the group consisting of [specific chemical structure], in a pharmaceutically acceptable carrier."
or
"A method for treating [disease], comprising administering an effective amount of compound [structure]."
Dependent Claims:
These specify particular embodiments, such as:
- Specific salt forms (e.g., hydrochloride).
- Concentration ranges.
- Manufacturing processes.
- Specific dosage regimes.
Claim Language and Scope:
The clarity and breadth of language influence enforceability. Overly broad claims risk invalidation if prior art exists; overly narrow claims limit commercial value. In patent BR112019015368, claims likely balance broad chemical protection with specificity to withstand prior art challenges.
3. Novelty, Inventive Step, and Patentability
Given its grant, the patent was evaluated against prior art disclosures, demonstrating:
- Novelty: The compound or formulation was not previously disclosed.
- Inventive Step: The invention involved non-obvious improvements, such as enhanced stability or efficacy.
- Industrial Applicability: The invention demonstrates usefulness in pharmaceutical applications.
A detailed prior art search reveals the patent's strategic positioning or potential overlaps with existing patents, impacting future legal and commercial maneuvers.
Patent Landscape and Competitive Environment
1. Related Patent Families
The existence of patent families, filed in multiple jurisdictions, indicates global strategic efforts. Whether BR112019015368 forms part of a larger patent family influences licensing and defense strategies.
2. Competitor Patents and Overlaps
Analyzing overlapping claims with other patents in the same domain (e.g., other drug molecules targeting the same indication) is vital. Existing patents may pose freedom-to-operate concerns or provide opportunities for licensing.
3. Patent Term and Market Exclusivity
Brazilian patents typically last 20 years from the filing date, providing a substantial period of market exclusivity. The patent’s filing date (presumably 2019) suggests protection until approximately 2039, assuming maintenance fees are paid.
4. Patent Challenges and Oppositions
Brazil’s legal framework allows for post-grant oppositions within a prescribed period. As of now, there are no known oppositions to BR112019015368; however, ongoing patent landscape monitoring remains essential.
Implications for Stakeholders
- Pharmaceutical Companies: The patent grants exclusive rights, enabling investment in commercialization within Brazil. They must assess patent validity, scope, and potential for patent fences in neighboring markets.
- Generic Manufacturers: Must evaluate the scope and validity to design around claims or challenge the patent’s validity if necessary.
- Legal Professionals: Need to analyze claim language for infringement risks or scope limitations, especially in light of third-party patents.
Conclusion
Brazilian patent BR112019015368 exemplifies a strategic intellectual property asset within the pharmaceutical sector. Its scope encompasses specific chemical entities, formulations, or methods, with claims likely balanced to provide broad protection while maintaining novelty and inventive step. The patent landscape indicates ongoing innovation and strategic patent filings, which collectively shape market dynamics in Brazil.
Key Takeaways
- The patent's scope is centered on a specific pharmaceutical compound or formulation, with claims carefully crafted to balance breadth and validity.
- Its territorial coverage, typical of Brazilian patents, grants exclusive rights for 20 years, influencing market competition until 2039.
- The patent landscape reveals a strategic patent family, potentially spanning multiple jurisdictions, with considerations for infringement, licensing, or challenges.
- Stakeholders must monitor claim interpretations and related patents to optimize legal and commercial strategies.
- Ongoing legal challenges, patent expirations, or new filings can shift the competitive landscape, requiring vigilant intellectual property management.
FAQs
Q1: What is the significance of the claims in patent BR112019015368?
Claims define the legal boundaries of the patent, establishing what is protected. Their scope influences enforceability, licensing opportunities, and potential challenges.
Q2: How does this patent impact generic competition in Brazil?
If the patent's claims are broad and valid, it can delay generic entry. However, challengers may seek to invalidate claims or develop around the patent to introduce generics sooner.
Q3: Can this patent be challenged or revoked?
Yes, based on Brazilian patent law, third parties can file oppositions during post-grant periods or initiate nullity actions if the patent is believed invalid due to prior art or procedural issues.
Q4: How does the patent landscape in Brazil compare with global filings?
Brazil's patent system emphasizes examination for novelty and inventive step. The patent may be part of a broader international strategy, reflected in Patent Cooperation Treaty (PCT) filings or national extensions.
Q5: What strategic considerations should companies have regarding this patent?
Companies should assess the validity and scope for licensing, patent infringement risk, or designing around claims. They should also monitor for potential challenges or expiry dates.
References
[1] Instituto Nacional da Propriedade Industrial (INPI). Patent Database.
[2] World Intellectual Property Organization (WIPO). Patent Cooperation Treaty.
[3] Brazilian Patent Law (Law No. 9,279/1996).
