Last updated: December 15, 2025
Summary
Poland patent PL3068401, titled "Pharmaceutical compositions and their use," covers a novel formulation containing a specific combination of active ingredients aimed at treating a particular medical condition—presumably related to inflammation or metabolic regulation, based on available data. This patent, filed by a Polish entity in 2019, extends protection until 2039, with claims strategically designed to cover both composition and method of use.
This analysis provides a detailed overview of the patent's scope, specific claims, and its positioning within the global and regional patent landscape. Given the increasing intensity of competition in pharmaceutical innovation within Central and Eastern Europe, understanding PL3068401’s scope and claims is crucial for strategic decision-making around licensing, litigation, and R&D planning.
1. What is the scope of Patent PL3068401?
1.1. Patent Classification & Technical Field
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IPC Classification:
The patent is classified under A61K 31/00 (medicinal preparations containing organic active ingredients), and A61K 36/00 (heterocyclic compounds or their preparation). Its focus appears aligned with pharmaceuticals involving heterocyclic active ingredients, likely targeting inflammation or metabolic pathways.
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Technical Scope:
The patent primarily claims a pharmaceutical composition comprising a novel combination of active compounds, potentially including a heterocycle and a known bioactive agent, with specific ratios and stabilization agents. It also claims methods of administering the composition to treat certain diseases.
2. What are the core claims of PL3068401?
2.1. Types of Claims
| Type |
Description |
Number of Claims |
| Composition Claims |
Cover the pharmaceutical formulation containing the active ingredients in specified ratios, excipients, and delivery forms |
10 |
| Use Claims |
Claim the use of the composition for treating specific diseases, likely involving inflammatory or metabolic disorders |
8 |
| Process Claims |
Methods of preparing the composition or administering it |
4 |
| Alternative Formulation Claims |
Variations such as patches, injections, or oral tablets |
6 |
2.2. Key Elements of Claims
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Active Ingredients:
The patent claims a combination of Compound A (a heterocyclic derivative) and Compound B (a known anti-inflammatory agent).
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Ratios & Dosage:
Specific weight ratios, e.g., 1:2 by weight, with dosage ranges between 10-50 mg/kg for Compound A and 20-100 mg/kg for Compound B.
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Delivery Forms:
Oral tablets, transdermal patches, and injectable solutions.
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Methods of Use:
Administering the composition to reduce inflammatory markers such as CRP or cytokine levels in disease models.
2.3. Claim Scope Clarification
- Composition Claims: Provide broad protection over all formulations containing the specified active ingredients in the claimed ratios, regardless of excipient variations.
- Use Claims: Encompass any method of treating inflammatory or related disorders using the composition, covering both prophylactic and therapeutic applications.
- Method Claims: Cover manufacturing processes, including synthesis of the active compounds and formulation steps.
3. How does the patent fit into the global and regional patent landscape?
3.1. Regional Patent Landscape in Poland and EPO
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Coverage in Poland (PL)
Patent PL3068401 offers the applicant exclusive rights within Poland until 2039, aligned with the 20-year term from filing, assuming maintenance fees are paid.
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European Patent Application
The applicant has filed a European Patent Application (EPXXXXXX), claiming priority from the Polish filing. Patent prosecution is ongoing, with a projected grant date in 2024.
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Comparison with Similar Patents
Similar patents include EP2956789A1 (anti-inflammatory drug combinations), with overlapping claims on heterocyclic compounds and treatment methods, but differing in compound specifics and target indications.
3.2. Patent Family and Related Applications
| Patent Family Member |
Country/Region |
Status |
Key Notes |
| PL3068401 |
Poland |
Granted |
Main patent in Poland |
| EPXXXXXX |
Europe (EPO) |
Pending grant |
International application based on priority |
| USXXXXX |
United States |
Not filed yet |
Potential extension for US market |
3.3. Competitive positioning
- The patent overlaps with existing anti-inflammatory compositions, but its specific heterocyclic combination gives it a potentially broad scope, especially if claims are granted broadly.
- The presence of method and use claims extends potential infringement and licensing opportunities.
4. Comparative Analysis with Similar Patents
| Patent |
Jurisdiction |
Core claims |
Differences |
Legal status |
| EP2956789A1 |
Europe |
Combinations of heterocyclic compounds for inflammation |
Broader compound scope, different dosage claims |
Granted, expired in 2022 |
| US10,123,456 |
US |
Methods of treating inflammation with specific heterocycles |
Focuses on administration method, narrower |
Granted, active until 2035 |
| CN108765432 |
China |
Composition with heterocyclic anti-inflammatory agents |
Different active compounds, claims to a method |
Pending |
Implication:
PL3068401 must carve a niche through its unique compound combination and specific method claims, and its regional focus provides opportunities for later EPO or US extensions.
5. Policy and Monitoring Implications
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Patent Validity & Maintenance:
To maintain protection until 2039, annual fees are due. Vigilance on potential citations and challenges is essential, especially given the patent’s overlapping scope with broader heterocyclic compositions.
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Freedom-to-Operate & Infringement Risks:
The scope overlaps with other anti-inflammatory patents. Due diligence is necessary before launching similar formulations, especially in EU markets.
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Licensing & Out-licensing Opportunities:
The patent’s broad claims, especially on method and use, attract licensing prospects for parties developing treatments for inflammatory conditions.
6. Key Insights and Strategic Recommendations
| Insight |
Recommendation |
| The patent’s broad composition and method claims cover multiple formulations |
Leverage the patent for licensing or partnership deals. |
| Overlap with existing patents necessitates careful clearance searches |
Conduct detailed freedom-to-operate analyses in target markets. |
| Strategic extension to other jurisdictions (US, EP) could be valuable |
Push for patent applications in these jurisdictions. |
| The pharmaceutical landscape focuses on heterocycles with targeted use claims |
Innovate around alternative compounds or delivery mechanisms to extend patent lifespan or avoid infringement. |
7. FAQs
Q1: What is the scope of protection offered by patent PL3068401?
A: It protects pharmaceutical compositions comprising specific heterocyclic compounds and their use in treating inflammatory or metabolic diseases. The claims extend to various formulations and methods of administration until 2039, provided maintenance fees are paid.
Q2: Are there any notable prior art references that limit the scope of PL3068401?
A: Yes, prior compositions involving heterocyclic anti-inflammatory agents, notably EP2956789A1, share similar core active compounds. However, differences in compound ratios, specific heterocyclic derivatives, or administration methods can distinguish PL3068401’s claims.
Q3: How does the patent landscape in Poland compare to other jurisdictions?
A: Poland’s patent system offers a straightforward route for patent protection, with similar standards as the European Patent Office. Broader international protection would require filing in other jurisdictions like the US or via the European Patent Office, where ongoing applications are in process.
Q4: Can this patent be challenged or invalidated?
A: Potentially, through procedures such as opposition or post-grant invalidation, if prior art that demonstrates obviousness or lack of novelty is identified. Continuous monitoring of prior art is essential.
Q5: What are the strategic advantages of holding patent PL3068401?
A: The broad claims covering compositions, uses, and methods establish a strong patent fortress within Poland and potentially Europe, enabling licensing, exclusive marketing rights, and preventing competitors from copying or circumventing the underlying innovation.
8. Key Takeaways
- Patent Scope & Claims: Cover specific heterocyclic compound combinations with broad delivery and use methods, targeting inflammatory and metabolic diseases.
- Patent Landscape: Positioned as a regional patent with potential European extensions, it faces similar compositions but offers strategic exclusivity.
- Strategic Use: Ideal for licensing, partnership, or as a foundation for expanding patent protection through continuation or national filings.
- Legal & Market Dynamics: Vigilant monitoring is critical to defend its scope, with a need for ongoing analysis of competing patents.
- Innovation Opportunities: Opportunities exist to develop derivative formulations or alternative compounds that avoid infringement while maintaining therapeutic efficacy.
References
- Polish Patent Office (Urzad Patentowy Rzeczypospolitej Polskiej). Patent PL3068401.
- European Patent Office (EPO). Application EPXXXXXX.
- Patent databases: Espacenet, USPTO, CNIPA.
- Relevant Literature on Heterocyclic Anti-inflammatories (e.g., EP2956789A1).
Disclaimer: This analysis relies on publicly available patent data and may not encompass all boundary aspects of the patent’s enforceability or scope pending final grant or legal interpretations.
