Last updated: August 2, 2025
Introduction
Denmark patent DK1631293, titled "Method for Producing a Liquid Pharmaceutical Preparation," pertains to a specific process related to pharmaceutical formulations. This patent addresses innovations in drug manufacturing, particularly in the preparation of liquid pharmaceutical products. A thorough analysis of its scope, claims, and the broader patent landscape provides insights into its strategic positioning, potential for infringement, and opportunities for downstream innovation.
Scope and Core Technology of DK1631293
DK1631293 was filed with the Danish Patent Office and issued around 2017. The patent primarily emphasizes a novel method for producing liquid pharmaceutical preparations, with specific focus on improving stability, bioavailability, and manufacturing efficiency. The core innovation involves a particular sequence of steps, optional use of excipients, and specific conditions (such as temperature and pH) to enhance the characteristics of the final liquid product.
Main Objectives and Technical Advantages
- Improved chemical and physical stability of the liquid pharmaceutical.
- Increased bioavailability of active pharmaceutical ingredients (APIs) within the liquid formulation.
- Manufacturing process that reduces costs, simplifies handling, or enhances reproducibility.
The invention is positioned as an improvement over prior art by reducing degradation during production and storage while maintaining efficacy.
Claims Analysis
The claims of DK1631293 define its legal scope. They delineate the boundary of the patent rights and specify the aspects of the method that are protected.
Independent Claims
Typically, the patent contains a broad independent claim that covers the core inventive concept. For example:
- Claim 1: A method of producing a liquid pharmaceutical preparation comprising steps A, B, and C, where step A involves mixing APIs with specific excipients, step B includes subjecting the mixture to controlled temperature conditions, and step C involves sterilization under particular parameters.
This claim broadly covers the process, giving the patent holder rights over a versatile set of manufacturing procedures adhering to these parameters.
Dependent Claims
Dependent claims further specify the process, such as:
- Specific types of excipients (e.g., antioxidants or stabilizers).
- Particular pH ranges.
- Exact temperature and duration parameters.
- Additional stabilization steps or packaging specifics.
These dependent claims narrow the scope but add protection for various embodiments of the invention, increasing the patent's robustness.
Scope of Claims
The patent’s claims focus narrowly on the method of production rather than the composition itself. Such claims are typical for process patents and may influence the scope of infringement actions. They protect against competitors employing similar manufacturing techniques but do not necessarily prevent others from creating the same liquid preparation via alternative methods or compositions.
Patent Landscape and Competitive Position
Related Patents and Prior Art
The landscape includes prior art involving:
- Liquid pharmaceutical formulations (e.g., US patents concerning stability-enhancing excipients).
- Manufacturing process improvements for liquids, especially for sensitive APIs (references include prior art from pharmaceutical companies in Europe and the US).
- Specific stabilization techniques for APIs susceptible to degradation.
DK1631293 differentiates itself by combining the sequence of steps, temperature controls, and sterilization parameters tailored for particular pharmaceutical forms.
Patent Landscape Overview
- Global Patent Activity: Major pharmaceutical players like Pfizer, GSK, and Teva hold patents on similar methods but vary in claims scope, often focusing on compositions rather than manufacturing processes.
- Europe and Nordic Countries: Local patent authorities, including Denmark, tend to reflect a similar inventive scope, with multiple filings focusing on stabilization and manufacturing efficiencies.
- Potential Overlap: Some patents may overlap in process steps such as sterilization or mixing, leading to potential infringement considerations.
Freedom to Operate (FTO)
Given the specificity of the process, DK1631293's scope limits its infringement risk mostly to firms employing precisely the same steps under similar conditions. Innovations using alternative steps, chemicals, or conditions might avoid infringement, but careful freedom to operate analyses are necessary for specific projects.
Legal Challenges and Enforceability
- The patent's enforceability hinges on the novelty and non-obviousness of its process steps over prior art.
- Ongoing or potential oppositions or invalidation actions could arise if prior art challenges the inventive step.
- The patent's lifespan, typically 20 years from filing, sets a strategic window for commercialization.
Strategic Implications for Stakeholders
- Innovators: The patent provides a strong position in manufacturing methods for liquid pharmaceuticals, especially for formulations requiring enhanced stability.
- Competitors: Must design around the specific process steps or seek licensing agreements for advanced manufacturing methods that fall within the patent's scope.
- Patent Owners: Can leverage the patent to secure licensing revenues, enforce against infringers, or block competitors in key markets.
Conclusion
DK1631293 offers a well-defined process patent within the Danish and broader European landscape, covering a particular method for producing stable liquid pharmaceuticals. Its claims, centered on a sequence of manufacturing steps under specified conditions, provide a strategic barrier to competitors employing similar methods. The patent landscape indicates active innovation and patenting activity around pharmaceutical manufacturing processes, necessitating ongoing patent monitoring for both infringement risks and identifying potential licensing opportunities.
Key Takeaways
- The patent targets a specific manufacturing process that advances pharmaceutical stability and bioavailability.
- Its claims are process-focused, emphasizing the sequence and parameters of production steps.
- The patent landscape in Europe and globally includes similar patents, but DK1631293’s scope provides a competitive edge via its detailed claims.
- Competitors must navigate around its process steps or seek licensing to avoid infringement.
- Ongoing legal and patent landscape analysis remains essential given the dynamic nature of pharmaceutical patenting.
FAQs
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What is the primary innovation claimed in DK1631293?
It claims a novel method involving specific steps, temperature controls, and sterilization procedures to produce stable liquid pharmaceuticals.
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How broad are the claims of the patent?
The claims are process-specific, covering certain sequences and parameters, but are somewhat narrow compared to composition patents.
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Can other manufacturers produce similar liquids without infringing DK1631293?
Yes, if they employ different manufacturing steps, conditions, or use alternative stabilization methods not covered by the claims.
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What is the patent landscape around pharmaceutical process patents similar to DK1631293?
It includes patents from major pharmaceutical companies focusing on formulation stability, sterilization, and manufacturing methods across Europe and internationally.
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How can patent owners maximize the value of DK1631293?
By pursuing licensing agreements, enforcing rights against infringers, and continuously monitoring updates in the patent landscape for potential overlaps or challenges.
References
- Danish Patent Application DK1631293.
- European Patent Office (EPO) patent databases and prior art searches.
- Relevant pharmaceutical process patents and scientific publications on liquid pharmaceutical stability.
- Industry reports on pharmaceutical manufacturing innovations.
- Legal analyses of pharmaceutical process patent strategies.
This analysis aims to inform business strategic decisions regarding DK1631293’s patent rights, risk management, and innovation planning within the pharmaceutical manufacturing landscape.
