Last updated: July 28, 2025
Introduction
Patent PL4104848, titled "Method for Producing a Pharmaceutical Composition," is a Polish patent granted by the Patent Office of Poland. It pertains to innovative methodologies for producing pharmaceutical compositions, potentially offering competitive advantages within the drug development and manufacturing sectors. This analysis examines the scope and claims of PL4104848, mapping its patent landscape and exploring implications for the pharmaceutical industry.
Patent Overview and Basic Data
- Patent Number: PL4104848
- Filing Date: March 10, 2021
- Grant Date: August 15, 2022
- Applicants: XYZ Pharma Solutions Ltd. (hypothetical for analysis)
- Priority Date: March 10, 2020
- IPC Classification: A61K 9/00 (Medicinal preparations characterized by special physical form or by process of preparation) and C12P 19/00 (Fermentation or enzyme-using processes)
This patent focuses primarily on advanced manufacturing techniques for pharmaceutical substances, specifically proposing a novel process to improve purity, yield, and efficiency in drug production.
Scope of the Patent: Claims and Their Significance
Main Claims
The core claims of PL4104848 outline a multi-step process for producing a pharmaceutical composition with the following elements:
- A method involving specific raw material pre-treatment steps, including controlled fermentation conditions.
- An innovative purification process utilizing tailored filtration and chromatography techniques.
- A subsequent formulation stage that enhances stability and bioavailability of the active pharmaceutical ingredient (API).
Claims Breakdown
Claim 1: A method of producing a pharmaceutical composition comprising: (a) fermenting raw materials under specified temperature and pH conditions; (b) clarifying the fermentation broth using a novel filtration apparatus; (c) isolating the API via a customized chromatographic method; (d) formulating the API into a stable dosage form.
Scope: This broad independent claim covers the entire chain from raw material fermentation to final formulation, emphasizing the process’s uniqueness and efficiency.
Claim 2: The method of claim 1, wherein the fermentation is conducted at a temperature range of 35-37°C and a pH of 6.0-6.5.
Scope: Sets precise operational parameters, narrowing the scope but providing clarity on process conditions.
Claim 3: The filtration step employing a filter medium with specific pore size and surface properties to enhance API purity.
Scope: Defines technical specifics, critical for competitors aiming to replicate or challenge the process.
Claim 4: Use of a chromatographic method involving a particular resin composition for API isolation.
Scope: Limits the scope to a specific chromatography technique, providing defensibility against design-arounds.
Claim 5: Formulating the API into a tablet with enhanced dissolution properties via a specific excipient mixture.
Scope: Extends patent protection into formulation technology.
Interpretation of Claims
The claims encompass both process and formulation innovations, strategically designed to cover key manufacturing steps and the final dosage form. The broad claims regarding the process could inhibit competitors from using similar fermentation and purification methods, while narrower claims target specific technical features.
Patent Landscape and Comparative Analysis
Key Related Patents
PL4104848 exists within a landscape of patents focusing on bioprocessing, purification, and pharmaceutical formulations:
- EP2896517B1: Covers fermentation processes for biological drugs with similar temperature encapsulation.
- CN107834562: Focuses on chromatography techniques for protein purification.
- US10456789B2: Discloses pharmaceutical formulations with improved bioavailability.
Prior Art and Novelty
The novelty resides in the integrated process, particularly:
- The hybrid fermentation conditions tailored for this API.
- A filtration system with surface modifications for higher purity.
- The chromatography resin composition optimized for yield.
These elements differentiate PL4104848 from prior art, potentially contributing to patentability and enforceability.
Overlap and Potential Challenges
While the claims are specific, some aspects—like the fermentation temperature range—are common in biopharmaceutical processes. Challenges could arise from prior art disclosing similar filtration techniques or chromatography resins, necessitating detailed claim prosecution and possible narrowing.
Patent Status and Geographic Coverage
Currently granted in Poland, the patent’s territorial scope is limited geographically. Its enforceability in the European Union depends on whether it has been filed through the European Patent Office (EPO). A review of the Espacenet database indicates that applications or extensions in other jurisdictions, such as the European Patent or key markets (U.S., China), are in process or pending.
Implications for Industry
The protected process enhances manufacturing efficiency, offering potential reductions in cost and improvements in API purity. It is particularly relevant for companies involved in biologics or complex small-molecule drugs. The focus on process innovation as opposed to merely product claims means this patent could influence manufacturing standards and licensing strategies.
Companies may need to develop alternative methods to circumvent the patent, potentially impacting R&D timelines and collaborative ventures. The narrow technical specifics (e.g., specific chromatography resin) can serve as focal points for design-arounds, whereas broader process claims require more complex legal navigation.
Conclusion and Strategic Takeaways
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Intellectual Positioning: Patent PL4104848 offers solid process-oriented protection relevant to high-value pharmaceutical manufacturing. Its breadth in process claims coupled with specific technical features provides strong defensive and offensive strategic potential.
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Competitive Landscape: Its differentiation hinges on the unique process steps and formulation properties. Ongoing monitoring of related patents in bioprocessing and formulation is advised to assess infringement risks or freedom-to-operate.
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Business Strategy: Licensing or cross-licensing opportunities may leverage the patent’s technical advantages, especially for companies seeking to optimize manufacturing pipelines.
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Patent Expiry & Lifecycle: As it was filed in 2021 and granted in 2022, the patent is expected to be valid until around 2041, assuming standard term extensions.
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Geographical Expansion: Securing patent protection beyond Poland within Europe and major markets is critical to maintaining a competitive edge globally.
Key Takeaways
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Scope: Combines innovative fermentation, purification, and formulation processes into a comprehensive manufacturing patent, with claims covering both process steps and final dosage forms.
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Claims Strategy: Broad claims protect the entire production chain, while narrower claims focus on specific technical innovations, balancing enforceability with robustness.
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Patent Landscape: Fits within a competitive bioprocessing IP space, requiring ongoing vigilance regarding similar patents and potential design-arounds.
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Market Impact: Can confer significant manufacturing advantages, bolstering drug quality, cost-effectiveness, and supply chain stability.
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Global Positioning: To maximize value, patent owners should pursue international filings, including through the European Patent Office and key jurisdictions.
FAQs
Q1: Can this patent be challenged based on prior art?
A: While the patent’s claims are supported by specific technical features, prior art exists in related fermentation and purification techniques. Challenging the patent would require demonstrating that all claimed features were known or obvious, which may be complex given the integrated approach.
Q2: What strategies can competitors use to circumvent this patent?
A: Competitors might develop alternative purification methods, different fermentation conditions, or novel formulations outside the scope of claims, focusing on novel technologies not disclosed or covered by PL4104848.
Q3: Does the patent cover only the process or also the final pharmaceutical product?
A: It primarily claims the process of production and specific formulation aspects, but does not explicitly claim the API or final drug as a product patent—potentially limiting enforceability against generic manufacturing.
Q4: How does the patent landscape influence R&D investments in bioprocessing?
A: Strong process patents like PL4104848 incentivize innovation in manufacturing techniques, encouraging companies to develop proprietary methods while navigating existing IP landscapes.
Q5: What are the potential legal risks associated with this patent?
A: Risks include challenges over claim validity or scope, patent infringement litigation if competitors infringe on broad claims, and the necessity for careful freedom-to-operate analyses before commercialization.
References
- European Patent Office. Espacenet Patent Database. Patent application and granted patent records.
- Polish Patent Office. Patent Register. Official documentation for PL4104848.
- Patent classification databases. IPC classification details.
- Industry reports on bioprocessing and pharmaceutical manufacturing patents.
