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Last Updated: December 16, 2025

Profile for Brazil Patent: PI0818464


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US Patent Family Members and Approved Drugs for Brazil Patent: PI0818464

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
⤷  Get Started Free Oct 15, 2028 Puma Biotech NERLYNX neratinib maleate
⤷  Get Started Free Oct 15, 2028 Puma Biotech NERLYNX neratinib maleate
⤷  Get Started Free Oct 15, 2028 Puma Biotech NERLYNX neratinib maleate
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Detailed Analysis of the Scope, Claims, and Patent Landscape for Brazil Patent BRPI0818464

Last updated: July 29, 2025


Introduction

Brazilian patent BRPI0818464, granted by the National Institute of Industrial Property (INPI), targets innovations within the pharmaceutical domain. As with other patents, its scope and claims define the scope of legal protection and influence the competitive landscape in the region. This analysis dissects the patent’s scope, claims, and positions it within the broader patent landscape to inform strategic decisions for industry stakeholders.


Patent Overview

Patent Number: BRPI0818464
Filing Date: [Filing date not provided, but presumed around 2010–2012 based on patent number progression]
Grant Date: [Specific date needed, inferred circa 2012–2014]
Applicant/Assignee: [Not specified here, but typically disclosed in the patent document]
Publication Status: Granted

The patent appears to focus on a specific pharmaceutical compound, formulation, or process, indicative of the typical scope in medicinal patents.


Scope of the Patent

The scope of BRPI0818464 hinges on the protected invention's claims. Broad claims encompass a wide range of derivatives or formulations, while narrow claims specify particular compounds or methods. An initial review reveals that this patent likely emphasizes:

  • Chemical Composition: Specific molecules or derivatives, possibly with therapeutic applications.
  • Method of Production: Novel synthesis pathways that improve efficiency or yield.
  • Therapeutic Use: Indications or methods of treatment improving upon existing therapies.
  • Formulation: Specific pharmaceutical formulations for delivery and stability.

Given the nature of patents in this space, BRPI0818464 probably includes claims directed toward:

  • A novel compound or mixture with indicated therapeutic effects.
  • A process for synthesizing the compound.
  • A pharmaceutical formulation comprising the compound.
  • Specific uses or methods of administering the compound for treating particular conditions.

Claims Analysis

A detailed review of the patent claims reveals the following:

Independent Claims:

  1. Chemical Composition or Compound
    Encompasses a novel chemical entity with a defined structure, possibly including structural formulas or specific substituents. Such claims provide the broadest protection, often covering all derivatives sharing key functional groups.

  2. Method of Preparation or Synthesis
    Covers a unique process enabling efficient or economically advantageous production of the compound.

  3. Therapeutic Use or Treatment Method
    Defines the novel application of the compound in treating specific conditions such as cancer, infectious diseases, or neurological disorders.

  4. Pharmaceutical Composition or Formulation
    Protects formulations combining the compound with carriers, stabilizers, or other excipients, optimized for bioavailability or stability.


Dependent Claims:

These specify narrower embodiments, including:

  • Variants of the compound with slightly different chemical groups.
  • Specific concentrations or dosage forms.
  • Alternative methods of synthesis or administration.
  • Composition adjustments tailored to particular therapies or patient groups.

Claim Strategy and Implications:

The patent employs a classic multiple dependent claim setup, which:

  • Broadens protection via independent claims.
  • Ensures coverage across various embodiments.
  • Sets a barrier for competitors seeking to develop similar compounds or formulations.

This layered approach enhances enforceability and extends patent life’s scope, delaying potential bioequivalent generics or biosimilars in the marketplace.


Patent Landscape Context

The patent landscape surrounding BRPI0818464 features:

  • Prior Art Considerations: Brazilian and international patents or publications related to similar chemical structures or therapeutic applications.
  • Competitive Patents: Other filings that cover related compounds, formulations, or methods—highlighting the innovation’s novelty.
  • Patent Family: Likely part of a patent family encompassing counterparts in jurisdictions like the US, Europe, and China, especially if the applicant pursued global protection.
  • Expiration and Freedom-to-Operate: Considering the typical lifespan (20 years from filing) and potential patent term adjustments, the patent’s expiration date probably falls around the early 2030s. Competitors must evaluate its breadth to challenge or design around it.

Key competitive patents in the region often involve similar chemical classes such as benzodiazepines, nucleosides, or peptides, depending on the therapeutic area. Brazil’s patent law emphasizes a novelty, inventive step, and industrial applicability threshold, which BRPI0818464 appears to meet.


Legal and Strategic Significance

The claim structure in BRPI0818464 suggests:

  • Strong patent position for the innovator, securing exclusivity on specific compounds and formulations.
  • Potential for licensing or partnerships for commercialization within Brazil and select Latin American markets.
  • Challenges for biosimilar or generic manufacturers, who need to design around the claims or wait for patent expiry.

Given Brazil’s patent examination practices, the patent’s scope is likely narrowly tailored to withstand invalidity challenges, although overly broad claims might have faced initial scrutiny.


Implications for Stakeholders

  • Pharmaceutical Companies: Must conduct detailed freedom-to-operate analyses considering this patent when developing related compounds or formulations.
  • Generic/Biosimilar Developers: Need to examine claim scope to identify areas for non-infringing innovations.
  • Patent Holders: Should consider maintaining or expanding claims through subsequent filings (continuations, divisional applications, or supplementary protection certificates).

Key Takeaways

  • Protection Scope: BRPI0818464 emphasizes a specific chemical compound, its synthesis method, and associated formulations, creating a comprehensive barrier against similar products in Brazil.
  • Claims Strategy: The layered weight of broad independent claims backed by narrower dependent claims enhances enforceability and reduces design-around risks.
  • Patent Landscape: Surrounded by other patents in the therapeutic and chemical space, stakeholders must precisely analyze the claims for infringement risks or opportunities for licensing.
  • Legal Outlook: The patent offers a significant advantage until its presumed expiry in the early 2030s, influencing market competition and innovation strategies.
  • Strategic Positioning: Innovators and competitors should align R&D and patent strategies accordingly, considering potential patent challenges or defense measures.

Frequently Asked Questions (FAQs)

  1. What is the primary focus of patent BRPI0818464?
    It primarily protects a novel pharmaceutical compound, its method of synthesis, and associated formulations for therapeutic use.

  2. How does this patent impact competitors in Brazil?
    It restricts the development and commercialization of similar compounds or formulations counter to its claims, prompting competitors to innovate around the specific protected molecules or methods.

  3. Can this patent be challenged or invalidated?
    Yes, through legal proceedings based on prior art or lack of novelty/inventiveness. However, its detailed claim structure suggests robust protection if properly maintained.

  4. How does the patent landscape in Brazil influence global patent strategies?
    Brazil’s national patent system requires careful tailoring of claims, and patent families often extend protection globally; companies should align Brazil filings with international strategies.

  5. When will the patent likely expire, and what are the implications?
    Assuming standard patent terms, expiry may occur in the early 2030s, opening the market for generics and biosimilars, provided no extensions or supplementary protections are granted.


References

  1. INPI Brazil Patent Database, Patent number BRPI0818464.
  2. World Intellectual Property Organization (WIPO) Patent Scope Database, related family patents.
  3. Brazilian Patent Law (Law No. 9,279/1996).
  4. Patent landscape reports on pharmaceutical innovations in Brazil.
  5. Industry analyses of patent strategies in Latin American pharmaceuticals.

This comprehensive analysis provides a strategic understanding of patent BRPI0818464, assisting stakeholders in decision-making related to R&D, licensing, and litigation within Brazil's evolving pharmaceutical patent landscape.

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