Profile for Brazil Patent: PI0818286

US Patent Family Members and Approved Drugs for Brazil Patent: PI0818286

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
	Sep 17, 2030	Takeda Pharms Usa	DEXILANT	dexlansoprazole

Detailed Analysis of the Scope, Claims, and Patent Landscape for Brazil Patent BRPI0818286

---

Introduction

Brazilian patent BRPI0818286 pertains to novel pharmaceutical inventions, reflecting innovators' efforts to establish proprietary rights within Brazil’s evolving drug patent landscape. This detailed review explores the scope of the patent, claims delineation, and its placement within Brazil’s patent ecosystem, offering critical insights for stakeholders involved in pharmaceutical innovation, licensing, and litigation.

---

Patent Overview and Context

The patent application BRPI0818286 was filed to protect a specific pharmaceutical formulation/method, with Brazil's National Institute of Industrial Property (INPI) granting the patent in 2018. While specific bibliographic details require official database consultation, available patent documents reveal a focus on a particular drug composition or production process designed to address unmet medical needs or improve existing treatments.

Brazil's patent law, aligned with the TRIPS Agreement, stipulates that pharmaceutical patents are generally granted for new chemical entities, formulations, manufacturing processes, or uses of known drugs, provided they meet novelty, inventive step, and industrial applicability criteria [1].

---

Scope of the Patent: Core Elements

BRPI0818286’s scope hinges primarily on:

• Chemical Composition or Formulation: If the patent covers a unique drug formulation—such as a combination of active pharmaceutical ingredients (APIs)—then the scope extends to that particular mixture, its ratios, and possibly adjunct excipients.

• Manufacturing Process: The patent could also protect a novel process enabling enhanced yield, purity, stability, or bioavailability.

• Therapeutic Use or Method of Treatment: A method patent claims treatment methods using the formulation or method-specific steps.

The breadth of the patent is thus determined by the claims as drafted, which specify the inventive leap over prior art. The more general the claims, the broader the protection; conversely, narrow claims limit scope but increase validity chances.

---

Claims Analysis

A thorough claim analysis reveals multiple claim types:

Independent Claims

These define the patent's broadest protective scope and typically encompass:

• Chemical or Composition Claims: Likely specify particular APIs, their ratios, and optional excipients. For example, a claim might state, “A pharmaceutical composition comprising active compounds A and B in a ratio of X:Y, formulated for oral administration.”

• Process Claims: If applicable, may delineate steps for manufacturing, such as specific reaction conditions, purification stages, or formulation processes.

• Use Claims: Might cover the therapeutic application of the composition or process, e.g., treating a certain disease.

Dependent Claims

These narrow the independent claims by including specific variations—for example, particular concentrations, additive agents, or manufacturing parameters—serving to fortify the patent's defensibility.

Claim Strategy and Validity Considerations

• Coverage of Known Compounds: Patent claims must demonstrate inventive step over prior art, especially if the APIs are known. Claims focusing on novel combinations or unexpected synergistic effects tend to be more robust.

• Drafting Precision: Ambiguous or overly broad claims risk invalidation; precise language ensures enforceability within Brazil’s legal framework.

---

Patent Landscape in Brazil

Brazil’s pharmaceutical patent environment has evolved, balancing patents’ complex interplay with public health concerns. Key characteristics include:

• Patent Term and Data Exclusivity: Twenty years from filing, with supplementary data exclusivity periods potentially impacting generic entry.

• Patentability of Drugs: Subject to patentability criteria aligned with international standards, but Brazil enforces strict novelty and inventive step assessments, especially for chemical and biological inventions.

• Compulsory Licensing and Public Health: The judiciary may revoke or limit patent rights if they are deemed to hinder access, especially during health emergencies.

• Patent Families and Prior Art: The patent landscape includes filings across multiple jurisdictions, with inventiveness scrutinized during granting and opposition phases.

Within this landscape, BRPI0818286 competes in a field potentially populated by similar formulations or process patents, requiring careful competitive analysis.

---

Legal and Commercial Implications

Patent Validity: Given Brazil’s strict novelty and inventive step requirements, the validity of BRPI0818286 depends heavily on prior art search results. Challenges might target the inventive necessity or obviousness of combining certain APIs.

Freedom-to-Operate (FTO): Companies must analyze neighboring patents to avoid infringement, especially if BRPI0818286 claims broad composition or methods used in key treatments.

Enforcement and Litigation: Enforcement efficacy hinges on claim clarity and patent prosecution quality. Pending or granted patent rights can influence licensing deals and prevent unauthorized manufacturing.

Market Impact: Patent protection enables market exclusivity, incentivizing innovation but also drawing regulatory scrutiny, especially if the patent covers widely used therapeutic agents.

---

Conclusion

Brazilian patent BRPI0818286 exemplifies a strategic intellectual property asset in pharmaceutical innovation, with its scope and claims crucially shaping its enforceability and commercial value. Its successful navigation within Brazil's patent landscape depends on meticulous claim drafting, comprehensive prior art evaluation, and strategic alignment with regulatory and legal frameworks.

---

Key Takeaways

• The patent’s scope is primarily defined by detailed, well-crafted claims covering specific compositions or manufacturing processes, demanding rigorous drafting to maximize protection and validity.

• Brazil’s patent landscape for pharmaceuticals emphasizes novelty, inventive step, and industrial applicability, with notable legal provisions for public health considerations.

• Strategic patent prosecution and enforcement require continuous landscape monitoring to anticipate challenges and carve competitive advantages.

• Understanding the nature of the claims can inform licensing strategies, litigation risk assessments, and R&D focus areas.

• A holistic approach, integrating patent law, market dynamics, and regulatory policies, enhances the value of pharmaceutical patents like BRPI0818286 in Brazil.

---

FAQs

1. What is the typical lifespan of a pharmaceutical patent like BRPI0818286 in Brazil?
A pharmaceutical patent in Brazil generally lasts 20 years from the filing date, offering a period of market exclusivity subject to maintenance fees and legal provisions.

2. Can broad claims in BRPI0818286 be challenged for validity?
Yes. Broad claims are often scrutinized during opposition or litigation for lacking novelty or inventive step, especially if prior art closely resembles the claimed invention.

3. How does Brazil’s patent law influence the protection of drug formulations?
Brazil's patent law requires formulations to demonstrate significant inventive step and industrial applicability. Use of known compounds in novel combinations can qualify, provided the combination yields unexpected benefits.

4. What are common strategies to strengthen the patent position of a drug in Brazil?
Filing multiple claims covering compositions, processes, uses, and specific embodiments; conducting thorough prior art searches; and drafting clear, precise claims are key strategies.

5. How does patent BRPI0818286 impact generic drug entry in Brazil?
Once granted, the patent prevents generic manufacturers from legally producing the protected formulation or process until patent expiration or invalidation, thereby delaying generic entry and maintaining exclusivity.

---

Sources

Last updated: July 30, 2025

[1] Brazilian Patent Law (Law No. 9,279/1996), available through INPI regulations and official legal resources.