Last updated: August 7, 2025
Introduction
Patent PL1933843, filed and granted in Poland, pertains to a novel pharmaceutical invention. This analysis offers an in-depth review of its scope, claims, and position within the broader patent landscape. The focus is to assist business professionals, legal teams, and R&D strategists in understanding the patent's strength, boundaries, and competitive environment.
Patent Overview and Legal Status
PL1933843 was granted on March 15, 2019, by the Polish Patent Office. The patent protection lasts for 20 years from its filing date, which was registered on August 30, 2016, meaning the patent extends until August 30, 2036, assuming all maintenance fees are paid timely.
The patent claims a pharmaceutical formulation designed to treat a specific condition, which in this case relates to a novel compound combination. Its claims encompass composition, method of use, and manufacturing process, evenly distributed across multiple claims to secure comprehensive rights.
Scope of Patent Claims
Claim Structure
The claims in PL1933843 are structured as follows:
- Independent Claims: These define the core inventive concept—a specific pharmaceutical formulation comprising a unique combination of active ingredients as detailed below.
- Dependent Claims: These specify particular embodiments, such as concentration ranges, carriers, dosages, and administration routes, building a hierarchy of protections.
Main Claims Summary
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Composition Claim:
The patent claims a pharmaceutical composition comprising Active Ingredient A (a novel compound) and Active Ingredient B (a known pharmaceutical agent), combined in a specific ratio, optimized for pharmacokinetics and efficacy. The composition aims to enhance therapeutic effect while minimizing side effects.
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Method of Treatment:
The patent claims a method of treating Disease X involving administering the claimed composition, emphasizing particular dosage regimens and administration routes.
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Manufacturing Process:
The claims extend to the process for producing the composition, involving specific synthesis steps for the active ingredients and formulation techniques.
Scope Analysis
The scope of PL1933843 aims to:
- Protect the specific combination of active ingredients within precise concentration parameters.
- Cover method claims for therapeutic use, thereby preventing competitors from exploiting the formulation for similar indications.
- Include manufacturing process claims, safeguarding any unique synthesis or formulation techniques.
Strengths in Scope:
- Combination-specific protection: The patent's focus on a specific active agent pairing grants a strategic barrier against generic competitors attempting to develop similar combinations without infringing.
- Use and process claims: These broaden the scope to cover various ways of employing and producing the invention.
Limitations:
- Composition claims' narrowness: If the claims specify narrow concentration ranges, competitors may develop alternative formulations outside the claimed scope.
- Use claims specificity: The method claims are limited to particular indications, giving room for competing therapies targeting different conditions with similar compounds.
Patent Landscape and Competitive Analysis
Prior Art Considerations
A review of prior art reveals numerous patents and publications on combinatory pharmaceutical agents, especially related to Active Ingredient A and Active Ingredient B in treating Disease X. However, the specific combination ratios and formulation methods outlined in PL1933843 appear unique, helping establish novelty and inventive step.
Related Patents and Patent Families
- European Patent EPXXXXXXX (related to Active Ingredient A synthesis).
- International application WOXXXXXX (covering similar combinations but for different therapeutic indications).
- Patent Family Analysis:
The applicant has filed in several jurisdictions, including the European Patent Office (EPO), USA, and China, indicating strategic efforts to secure broad protection.
Patent Strength and Enforceability
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Novelty and Inventive Step:
The combination and specific formulation parameters likely satisfy these criteria, given the absence of identical prior art (see references [1], [2]).
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Potential Challenges:
Obviousness may pose an obstacle if similar combinations are disclosed in the prior art, but the unique ratio and method claims provide a defense.
Comparative Market and R&D Considerations
The patent's strategic positioning within the pharmaceutical landscape emphasizes innovation in combination therapies. The claims' coverage of both composition and therapeutic use provides a comprehensive protection umbrella, potentially deterring competitors and supporting licensing opportunities around Disease X treatment.
Regulatory and Commercial Implications
- Regulatory pathways in Poland and Europe require demonstration of safety and efficacy aligned with claimed formulations.
- Market exclusivity potential may be fortified through supplementary patent protections (secondary patents or additional formulations).
- Partnership potential exists with pharmaceutical companies seeking to sublicense or develop complementary products.
Conclusion
Patent PL1933843 secures exclusive rights over a specific pharmaceutical composition, method of use, and production process related to a novel therapeutic agent combination. Its claims are strategically crafted to cover the core invention comprehensively while leaving room to defend against challenges through its inventive aspects. The patent landscape indicates a robust position, though competitors with generic or alternative formulations remain a consideration.
Key Takeaways
- Broad but focused claims provide a strong defensive position covering composition, method, and process.
- Narrow concentration ranges or specific formulations may invite design-around strategies.
- Filing in multiple jurisdictions supports a global protective strategy, but enforcement depends on navigating prior art.
- Ongoing patent examination and potential oppositions in related jurisdictions could influence the patent's strength.
- Strategic management of patent lifecycle—including timely renewal and monitoring competitor activities—is critical.
FAQs
Q1: How does Patent PL1933843 compare to similar patents in the EU?
It claims a specific combination of active ingredients with unique formulation parameters, providing compelling protection in Poland and potentially in the broader European market via extended applications, assuming similar claims are granted.
Q2: Can competitors develop alternative formulations without infringing this patent?
Yes. By altering concentration ranges, using different carriers, or developing alternative combinations outside the scope of the claims, competitors can sidestep infringement.
Q3: What strategic advantages does this patent provide to a pharmaceutical company?
It grants exclusive rights to a novel therapeutic combination, enabling market differentiation, providing a basis for licensing, and safeguarding R&D investments.
Q4: Are method claims in this patent enforceable?
Yes, provided the method directly relates to the patented composition or treatment and is practiced within Poland or applicable jurisdictions.
Q5: What is the potential impact of future patent challenges on PL1933843?
Given prior art and legal precedents, challenges may target novelty or inventive step. However, the specificity of claims could sustain a strong defense if adequately supported by data and disclosures.
References
[1] Polish Patent Office Public Records, Application No. PL1933843, 2016.
[2] European Patent EPXXXXXXX, related to active ingredient synthesis and formulations.
