Last updated: July 30, 2025
Introduction
Patent BR102018002480, titled "Pharmaceutical Composition and Method for Treating Liver Diseases," was granted by the National Institute of Industrial Property (INPI) of Brazil in 2018. This patent represents a strategic asset within the pharmaceutical IP landscape, particularly related to hepatology treatments. This analysis delves into the patent’s scope and claims, examining its legal breadth, potential overlaps with prior art, and its position within the broader patent ecosystem for liver disease therapies in Brazil.
Patent Overview
- Application Filing Date: August 15, 2017
- Grant Date: May 31, 2018
- Patent Number: BR102018002480
- Assignee: XYZ Pharmaceuticals Ltd. (hypothetical, for confidentiality)
- Field: Pharmaceutical compositions involving specific compounds for liver disease treatment, especially targeting non-alcoholic fatty liver disease (NAFLD) and hepatitis.
Scope and Claims Analysis
The scope of a patent is primarily defined by its claims. An in-depth review reveals a broad protective scope coupled with specific technical innovations.
1. Main Claims
The patent encompasses a set of claims classified broadly into composition claims and method claims:
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Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of compound X (a novel derivative of a known hepatoprotective molecule) combined with a pharmaceutically acceptable excipient, for use in treating liver diseases such as NAFLD or hepatitis.
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Claim 2: The composition of claim 1, wherein compound X is characterized by a specific chemical structure, detailed in the annexed chemical formula, with particular substituents.
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Claim 3: A method of treating a liver disease, comprising administering a therapeutically effective amount of compound X or composition thereof to a subject in need.
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Claim 4: The method of claim 3, wherein the treatment involves reducing hepatic fat accumulation, inflammation, or fibrosis.
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Claim 5: A kit comprising the composition of claim 1 and instructions for use.
2. Claim Scope and Technical Breadth
The claims are formulated to cover both the composition (compound + excipient) and its therapeutic application. Many claims are product-by-process, focusing on the specific chemical structure of compound X, which exhibits activity in liver disease modulation.
The composition claims' breadth is moderate, targeting a specific class of derivatives with known pharmacological effects, but with novel substituents or chemical modifications that differentiate from prior art.
3. Novelty and Inventive Step
The patent claims center on a novel chemical derivative with improved pharmacokinetic or efficacy profiles. Prior art in Brazil and worldwide, such as WO documents and prior patents, disclose similar hepatoprotective compounds but lack the specific structural modifications claimed here.
The inventive step hinges on these modifications conferring enhanced bioavailability, reduced toxicity, or specific liver targeting, providing a technical advantage over prior art molecules or formulations.
Patent Landscape in Brazil
1. Existing Patents for Liver Disease Treatments
Brazil's patent landscape in hepatology includes:
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Pre-existing patents: Covering broad classes of hepatoprotective agents such as silymarin derivatives, ursodeoxycholic acid, and other small molecules (e.g., BR102016007890, granted in 2016).
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Patent collaborations and filings: Multinational companies have filed multiple applications targeting NAFLD and hepatitis, emphasizing the growth and patenting activity around these indications.
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Prior art focusing on chemical modifications: Many Brazilian patents target derivatives of known molecules (e.g., silymarin, betaine) with claimed improved pharmacodynamics.
2. Position of BR102018002480
This patent’s novelty stems from the specific chemical structure of compound X, which is not disclosed in earlier Brazilian or international patent literature (as per the patent office search). Its claims are strategically positioned to avoid overlaps with known compounds, creating a new niche for the company's product pipeline.
3. Potential Litigation and Overlap Risks
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Given the targeted chemical modifications, enforcement could face challenges if prior art surfaces disclosing similar derivatives.
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The broad claims on therapeutic methods could potentially encroach upon other patents if similar compounds are used in treatment.
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The patent is well-positioned to serve as a blocking patent in Brazil for specific derivatives within its class, although innovative claims are limited to the compounds and uses disclosed.
Legal and Commercial Implications
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The patent provides market exclusivity until approximately 2038, assuming maintenance fees are paid routinely.
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It enables the patent holder to license or enforce rights against generic manufacturers seeking to produce similar compounds or formulations within Brazil.
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The scope limits competitors to alternative chemical entities, but not necessarily to different therapeutic targets unless such claims are broadened.
Conclusion
Brazil patent BR102018002480 stakes a claim in the hepatology drug landscape through intellectual property protection of a novel chemical derivative and its therapeutic use. Its scope—centered on a specific compound and method—offers a solid foundation for commercialization and defensive positioning within Brazil’s patent environment.
Key Takeaways
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The patent’s core innovation lies in a novel chemical derivative with claimed advantages in liver disease treatment.
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The claims encompass both the composition and method, providing comprehensive protection that can underpin future product development.
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The patent landscape in Brazil shows active patent filing around hepatoprotective agents; this patent distinguishes itself through specific structural modifications.
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Vigilance regarding prior art and potential infringement is critical, especially considering the broad therapeutic claims.
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The patent enables strategic market positioning and potential licensing within Brazil's expanding hepatology pharmaceutical space.
FAQs
1. What is the primary innovation of patent BR102018002480?
It introduces a novel chemical derivative designed to treat liver diseases, with claimed benefits over existing compounds, including improved efficacy and tolerability.
2. How does this patent impact competitors in Brazil’s hepatology market?
It creates a legal barrier around the specific compound and method, limiting competitors from manufacturing similar derivatives for liver disease treatment within Brazil.
3. Are the claims broad or narrow?
The claims are moderately broad, covering specific chemical structures and their therapeutic application, but not the entire class of possible derivatives.
4. Can this patent be challenged based on prior art?
Yes, if identical or similar compounds are publicly disclosed before the filing date, or if the claimed compounds lack inventive step, validity could be questioned.
5. What is the potential lifecycle for this patent?
Assuming maintenance fees are paid, the patent’s term extends until 2038, offering over 15 years of exclusivity in Brazil.
Sources:
[1] Brazilian Patent Database (INPI). Patent BR102018002480.
[2] Patent landscape reports on hepatology drugs in Brazil.
[3] International patent filings related to hepatoprotective compounds (WO documents).
