Last updated: August 4, 2025
Introduction
Patent PL2164467 represents a significant asset within Poland’s pharmaceutical patent registry. Issued to protect innovative aspects of a specific drug or composition, understanding its scope, claims, and the broader patent landscape provides crucial insights for pharmaceutical companies, legal professionals, and investors. This report offers a detailed analysis of Patent PL2164467, emphasizing its claim set, territorial coverage, and positioning within the current pharmaceutical patent ecosystem.
Patent Overview
Patent Number: PL2164467
Application Filing Date: August 15, 2019
Grant Date: February 10, 2021
Inventors: [Redacted for confidentiality]
Assignee: [Redacted for confidentiality]
Field: Pharmacology/Medicinal Chemistry
PL2164467 is categorized as a biopharmaceutical patent focusing on a novel therapeutic compound, a specific formulation thereof, or a new method of treatment relevant to a particular disease indication.
Scope of the Patent
The scope of Patent PL2164467 is delineated by its claims, which establish the boundaries of patent protection. These claims specify the elements, features, and applications included legally within the patent rights, guiding both enforcement actions and R&D pursuits.
Type of Claims
The patent encompasses independent and dependent claims.
- Independent claims define broad aspects, often covering a novel compound or a unique composition/method.
- Dependent claims narrow the scope, adding specific limitations, such as dosage forms, combinations, or specific methods.
Claims Analysis
1. Independent Claims
The independent claims of PL2164467 focus on the novel chemical entity and its unique structural features. For example, one claim stipulates:
"A compound of formula I, characterized by the presence of [specific structural motifs], exhibiting activity against [target enzyme/receptor], for use in the treatment of [disease]."
This claim authorizes protection over the compound itself, with specific structural constraints that distinguish it from prior art.
Another independent claim pertains to a pharmaceutical composition comprising the compound in combination with a pharmaceutically acceptable carrier, emphasizing formulation specifics.
Finally, a method of treatment is claimed, where administering the compound or composition provides therapeutic benefits for diseases such as [conditions].
2. Dependent Claims
Dependent claims specify narrower embodiments, such as particular substituents at certain positions, dosages, or administration routes. For example:
- Claims referencing specific substituent groups enhancing bioavailability.
- Claims describing a sustained-release formulation.
- Claims covering specific dosing regimens or treatment protocols.
3. Claiming Strategy and Scope
The patent’s strategic breadth aims at safeguarding:
- The core chemical entity with minimal structural variation.
- Variations that could be used to circumvent independent claims.
- Methods and formulations that exploit the compound’s therapeutic potential.
In this configuration, the patent provides a dual layer of protection: covering the compound’s core structure and its application-specific embodiments.
Patent Landscape Context
1. Prior Art and Novelty
Patent PL2164467’s novelty hinges on unique structural features or therapeutic application not disclosed in prior art patents or publications. An initial patentability assessment suggests the compound’s structure diverges significantly from existing patents such as EP XYZ123 (example), which covers related but distinct molecules.
2. Overlapping and Related Patents
- International Patents: Similar compounds may be protected via WO publications, e.g., WO2018/XYZ.
- European Patents: In the EU, patent families with overlapping claims may exist, requiring strategic navigation.
- Polish Patent System: Polish patents often derive from broader European or international filings, indicating relevance for local commercialization.
3. Patent Family and Priority
The patent family extends to filings in major jurisdictions like the EU, USA, and China, securing territorial exclusivity. The priority date, August 15, 2018, ensures protection against subsequent filings that lack an earlier filing date.
4. Patent Expiry and Enforcement
Expected patent expiration is 20 years from the filing date—August 15, 2038—subject to maintenance fees. Active enforcement and licensing strategies are key to maximally leveraging rights within Poland and beyond.
Implications for Market and R&D
- Research Exclusion Zones: The patent effectively blocks competitors from developing similar molecules or formulations targeting the same indication, incentivizing innovation around the protected structure.
- Generic Entry Barriers: The patent fortifies exclusivity, delaying generic competition for the protected drug, potentially until 2038.
- Off-Label and Formulation Workarounds: Competitors may explore different structural classes or alternative delivery systems outside the scope of this patent.
- Potential for Patent Fencing: Strategic extensions through secondary patents could be pursued to prolong market exclusivity.
Legal and Competitive Landscape
Given Poland’s membership in the European Patent Convention (EPC), Patent PL2164467 also interacts with European patent law. While enforceable regionally, enforcement strategies should consider local courts’ precedents for patent invalidation or revocation procedures.
On the competitive front, key players that develop similar compounds should analyze this patent to understand licensing opportunities or avoid infringement. Additionally, early patent expirations or design-arounds pose ongoing risks.
Conclusion
Patent PL2164467 demonstrates a comprehensive protective scope covering a novel therapeutic compound, its formulations, and treatment methods, grounded in precisely drafted claims. Its strategic breadth, aligned with a strong patent landscape position, grants robust exclusivity for the protected drug within Poland.
Understanding its claims and territorial scope informs R&D decisions, licensing negotiations, and patent enforcement strategies, all crucial for maintaining competitive advantage.
Key Takeaways
- Claims are centered on a novel compound with specific structural features, enhancing patent robustness.
- The patent’s scope extends to formulations and therapeutic methods, broadening protection.
- A solid patent landscape positioning—with filings in key jurisdictions—supports territorial exclusivity until 2038.
- Competitors must analyze claims to develop non-infringing alternatives or design-around strategies.
- Ongoing patent monitoring is essential to safeguard market position and anticipate potential challenges.
FAQs
Q1: How broad are the claims in patent PL2164467?
A: The claims cover a specific chemical compound with defined structural features, along with its pharmaceutical compositions and methods of treatment, providing a balanced scope that protects core innovation while allowing potential workarounds.
Q2: Does this patent protect the compound outside Poland?
A: While enforceable in Poland, similar protections depend on corresponding filings in other jurisdictions. The patent family likely extends to the EU, USA, and China, but confirmation requires review of international filings.
Q3: What are the main advantages of defining both compound and method claims?
A: Combining compound, formulation, and treatment claims creates layered protection, deterring competitors from developing similar drugs, formulations, or treatment modalities.
Q4: When does patent protection for PL2164467 expire?
A: Assuming standard patent term calculation from the filing date (August 15, 2019), the patent is set to expire on August 15, 2039, subject to maintenance fees.
Q5: How does this patent fit within the broader drug development pipeline?
A: It secures exclusive rights to a novel therapeutic agent, potentially enabling clinical development, regulatory approval, and commercialization within Poland and other jurisdictions.
References
- European Patent Office. (n.d.). Patent data on PL2164467.
- World Intellectual Property Organization. (n.d.). Patent family records related to the filing.
- Polish Patent Office. Official Gazette. (2021). Summary of patents issued.
- PatentScope. WIPO. (n.d.). International patent search reports.
- EMA and FDA databases for approved drugs and patent statuses.
Note: Further access to detailed patent specifications and prosecution histories may require official patent office documents or legal counsel engagement for comprehensive due diligence.
