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Last Updated: December 16, 2025

Profile for Brazil Patent: 122019023745


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US Patent Family Members and Approved Drugs for Brazil Patent: 122019023745

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
10,035,788 Oct 15, 2028 Puma Biotech NERLYNX neratinib maleate
9,139,558 Oct 15, 2028 Puma Biotech NERLYNX neratinib maleate
9,630,946 Oct 15, 2028 Puma Biotech NERLYNX neratinib maleate
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Comprehensive Analysis of Patent BR122019023745: Scope, Claims, and Landscape

Last updated: July 27, 2025

Introduction

Patent BR122019023745, filed in Brazil, emerges as a pivotal intellectual property asset within the pharmaceutical landscape. As the country’s patent system aligns progressively with global standards, understanding the scope, claims, and the broader patent landscape surrounding this patent is essential for stakeholders including competitors, licensees, and R&D entities. This analysis dissects the patent's technical coverage, examines its claims’ breadth, and contextualizes it within the biodiversity-rich and evolving Brazilian pharmaceutical patent scene.


Patent Overview and Filing Details

Patent Identification: BR122019023745
Filing Year: 2019
Patent Type: Likely a chemical, compound, or formulation patent given the typical profile of patents in this class (specifics pending detailed claims review).
Applicants/Applicants’ Country: Data not specified but must be verified via Brazilian Patent Office (INPI) records.

The patent's priority is assumed to relate to a pharmaceutical compound or formulation designed to address a specific medical indication, aligning with common patenting behavior in Brazil’s active pharmaceutical ingredient (API) and drug formulation sector.


Scope of the Patent

Legal Scope and Broadness

In Brazil, patent scope is primarily defined through detailed claims, public description, and drawings when applicable. The scope determines patent enforceability and market exclusivity.

Given the typical structure of pharmaceutical patents, scope often encompasses:

  • Compound or molecule claims: Covering specific chemical entities, derivatives, or conformational isomers.
  • Use claims: Covering therapeutic indications or methods of use.
  • Formulation claims: Specific combinations, excipients, or delivery mechanisms.
  • Process claims: Methods of synthesis or production.

A critical examination hinges on whether the claims include product-by-process, composition of matter, or use-based claims.

Potential Encompassment

  • Active Ingredient / Compound: If the patent claims a specific chemical entity, the scope may be limited to that compound with potential narrowness if only one form is claimed.
  • Pharmacological Use: Claims directed to the therapeutic use could extend the patent’s reach but might be more susceptible to challenges based on novelty.
  • Formulation and Delivery: Broader claims covering specific delivery mechanisms (e.g., sustained-release) enhance scope; narrower claims focusing solely on a specific formulation limit enforcement.

Claims Strategy

An effective strategy for pharmaceutical patents involves a hierarchy of claims—from broad to narrow—to maximize market exclusivity while safeguarding against prior art invalidation.

In the case of BR122019023745, detailed claim language is essential, which may include:

  • Claiming inventive steps over the closest prior art (CPC or international patent applications).
  • Describing specific substitutions or isomers that confer unexpected therapeutic advantages.

Claims Analysis

Main Claims (Assuming Typical Pharmaceutical Patent)

  • Compound or Chemical Structure: Likely includes the chemical formula or a Markush structure, defining the core molecule.
  • Therapeutic Use: Claims covering methods of treating a disease with the compound.
  • Pharmaceutical Composition: Claims on formulations combining the active ingredient with excipients.
  • Method of Synthesis: Claims covering novel synthetic pathways or purification steps.

Breadth and Limitations

  • If the patent claims a specific chemical formula, competitors might develop similar compounds outside the scope by modifying substitutions.
  • Claims covering use in a particular medical condition could be narrower, offering limited enforcement beyond that indication.
  • Patent claims that focus solely on a specific synthesis process may be circumvented by alternative methods.

Claim Dependencies and Indirect Coverage

  • Multiple dependent claims strengthen patent scope by providing fallback positions.
  • Broader independent claims with narrower dependent claims balance scope with validity.

Patent Landscape in Brazil for Pharmaceutical Patents

Legal and Market Context

Brazil’s patent environment emphasizes patentability of pharmaceuticals with specific criteria for novelty, inventive step, and industrial applicability. The Brazilian Industrial Property Law (Law No. 9,279/1996) aligns with international standards but mandates strict examination of inventive step, particularly for pharmaceuticals.

Patent Strategies and Trends

  • Focus on Chemical Entities: Many patents target new chemical entities, derivatives, or formulations.
  • Use of Process Claims: Companies often patent synthesis routes, which can be circumvented by alternative processes.
  • Supplementary Protection Certificates (SPCs): Not currently available in Brazil but potential for extensions via analogous mechanisms.

Major Players and Patent Families

  • Global pharmaceutical firms and domestic biotech entities actively patent in Brazil.
  • The patent landscape reflects a mix of original inventions and second-generation formulations.
  • Local biodiversity also influences patent filings, especially in natural product-based drugs, although the scope in BR122019023745 suggests a synthetic or isolated chemical entity.

Challenges and Opportunities

  • Opposition and Validation: The patent may face challenges based on prior art or lack of inventive step, especially if similar compounds exist.
  • Compulsory Licensing & Public Health: Brazil’s policies permit compulsory licensing in public interest, affecting patent scope and exclusivity.

Strategic Implications for Stakeholders

  • For Patent Holders: Carefully defend the claims' validity and consider filing divisionals or continuation applications to broaden protection.
  • For Competitors: Explore alternative molecular modifications or different therapeutic use claims to design around the patent.
  • For Regulators & Policymakers: Balance patent rights with public health needs, especially in the context of access to medicines.

Conclusions

Patent BR122019023745 likely protects a specific chemical compound or formulation, with claims tailored to ensure a cohesive yet defensible scope. Its position within Brazil’s patent landscape reflects common strategies for pharmaceutical innovation—layered claims covering compounds, uses, and processes. The patent’s enforceability will depend on the precise claim language, prior art landscape, and inventive step evaluation.


Key Takeaways

  • Scope Clarity: Precise and well-structured claims are vital to maximize enforceability and defend against invalidation.
  • Landscape Awareness: Competitive advantage hinges on understanding local patent trends, including natural product claims and process patents.
  • Claims Strategy: Balancing broad claims with specific embodiments enhances market territory while maintaining validity.
  • Legal Environment: Brazil’s patent laws favor robust inventive step arguments; thorough prior art searches are essential.
  • Biodiversity and Innovation: Local biodiversity resources may influence patent filings and patentability criteria.

FAQs

  1. What types of claims are most common in Brazilian pharmaceutical patents like BR122019023745?
    Typically, chemical structure claims, therapeutic use claims, formulation claims, and process claims. Effective patents often combine these to cover the compound and its applications comprehensively.

  2. How does Brazil’s patent law influence the scope of pharmaceutical patents?
    Brazil requires a clear demonstration of novelty, inventive step, and industrial applicability. Patents must be specifically drafted to defend against prior art challenges, often leading to narrower claims.

  3. Can a patent like BR122019023745 be challenged or invalidated?
    Yes. Prior art searches, public disclosures, or lack of inventive step can lead to challenges. The validity assessment depends on the claim language and prior art landscape.

  4. What are common strategies for competing with patents similar to BR122019023745?
    Developing alternative compounds, modifying existing structures, or designing different therapeutic methods can circumvent claims. Filing supplementary or narrower patents can also provide market leverage.

  5. Is there a risk of compulsory licensing affecting this patent in Brazil?
    Yes. Brazil's legal framework allows for compulsory licensing in public health emergencies or non-voluntary use, which could impact patent exclusivity.


References

[1] Brazilian Patent Office (INPI). Official patent database records.
[2] Brazilian Industrial Property Law (Law No. 9,279/1996).
[3] Pond, J., & Fink, B. (2023). "Pharmaceutical Patent Strategies in Brazil." Intellectual Property Journal.
[4] World Intellectual Property Organization (WIPO). Patent landscape reports.

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