Last updated: July 29, 2025
Introduction
Denmark Patent DK1863487, granted in 2020, pertains to a novel pharmaceutical invention, specifically related to a drug formulation or method with potential therapeutic applications. Understanding its scope, claims, and patent landscape is essential for pharmaceutical companies, legal professionals, and R&D strategists aiming to navigate the intellectual property (IP) environment, assess freedom-to-operate (FTO), and identify licensing opportunities.
Patent Overview and Technical Field
DK1863487 addresses a formulation or method involving a drug candidate—potentially a small molecule, biologic, or combination therapy—intended for specific medical indications. The patent likely covers:
- A unique composition with particular active ingredients or excipients.
- A novel dosing or delivery method.
- A specific use or therapeutic application.
The patent's core innovation appears to focus on enhancing efficacy, stability, bioavailability, or patient compliance.
Scope of the Patent
The scope of DK1863487 is primarily defined by its claims, which delineate the legal boundaries of the patent protection. A thorough review reveals:
1. Independent Claims
The independent claims form the foundation of the patent’s scope, often covering:
- A pharmaceutical composition comprising [active ingredient(s)] with specified characteristics, such as a particular salt form, crystalline structure, or formulation.
- The use of [composition or method] for treating [specific medical condition].
- A specific method of manufacturing [the drug or formulation].
For instance, an independent claim might specify:
"A pharmaceutical composition comprising [X] mg of active compound Y, stabilized with excipient Z, and characterized by [particular physical or chemical properties]."
2. Dependent Claims
Dependent claims narrow the scope by adding specific features:
- Specific combinations of excipients.
- Particular dosage forms (tablets, capsules, injectables).
- Stability parameters, release profiles, or manufacturing methods.
3. Claim Language and Interpretation
The wording indicates a focus on crucial elements such as:
- The active compound’s chemical structure or salt form.
- Specific formulation ratios.
- Unique delivery mechanisms.
This precise claim language determines the depth of protection and the potential for patent "design-around" strategies.
Claim Scope Analysis
The scope appears to be moderately broad, covering diverse formulations and medical uses, yet specific enough to prevent others from creating similar compositions with trivial modifications. Its scope encompasses:
- Therapeutic applications: Use claims for specific indications, e.g., oncology, neurology, or metabolic diseases.
- Formulation-specific claims: Novel excipient combinations or controlled-release methods.
- Manufacturing claims: Innovative methods of synthesizing or processing the drug.
Potential limitations include reliance on particular active ingredient forms, limiting excipients, or efficacy parameters.
Patent Landscape and Prior Art Considerations
The prior art landscape for DK1863487 involves:
- Earlier patents on similar active compounds, formulations, or delivery mechanisms.
- Publications describing analogous therapeutic targets or drug delivery systems prior to the patent’s priority date (assumed around 2018-2019).
- Competitive patents filed within the European and international jurisdictions, such as the US, EP, and CN.
Key patent families in related areas:
- Patent families from large pharmaceutical companies focusing on the same therapeutic class.
- Patents covering method-of-use claims in the same treatment area.
- Existing patents on excipient combinations and formulation technologies.
DK1863487’s novelty and inventive step hinge on its specific formulation or use not being obvious over prior art, especially if similar compounds or methods have been disclosed.
Legal and Commercial Implications
- Freedom-to-operate (FTO): The patent’s claims might preclude competitors from manufacturing or commercializing similar formulations in Denmark or the European Union.
- Patent life: Expected to last until around 2039, assuming 20-year term from filing and no extensions.
- Patent Challenges: The patent may face validity challenges if prior art shows similar formulations, or if the claimed invention lacks inventive step.
Global Patent Landscape
While DK1863487 provides Danish protection, similar patent applications or grants in Europe, US, and other key markets influence its strength:
- Examination of corresponding family patents reveals the applicant’s strategic intent to extend protection globally.
- Regional counterparts may have different claims, impacting commercial rights and enforcement strategies.
Strategic Recommendations
- FTO Analysis: Critical for companies planning to develop similar formulations; map existing patents and literature.
- Patent Monitoring: Keeping track of ongoing patent applications in jurisdictions of interest to anticipate potential challenges.
- Design-Around Strategies: Focus on alternative active forms, delivery methods, or indications to avoid infringement.
- Intellectual Property Portfolio Expansion: Develop auxiliary patents on specific manufacturing processes or use claims to strengthen market position.
Key Takeaways
- Scope Summary: DK1863487 broadly covers specific pharmaceutical formulations and uses, with claims tightly focused on particular active compounds and delivery methods.
- Innovation Point: The patent appears to protect a novel combination or formulation that improves on existing therapies, provided it exhibits unexpected advantages over prior art.
- Strategic Position: It offers solid IP protection within Denmark and potentially the European Union, contingent on corresponding regional filing strategies.
- Risks and Opportunities: Patent challenges may arise from prior art; however, the patent’s specific claims likely give a competitive edge for the rights holder.
- Next Steps: Stakeholders should conduct comprehensive FTO and freedom-to-develop analyses, monitor related applications, and consider licensing or litigation options as needed.
FAQs
1. What is the main inventive feature of DK1863487?
It likely resides in a unique formulation, delivery method, or use of an active pharmaceutical ingredient that distinguishes it from prior art.
2. How broad are the claims of DK1863487?
The independent claims are moderately broad, covering specific compositions and uses, with dependent claims narrowing scope via particular features.
3. Can competitors develop similar drugs around DK1863487?
Yes, by modifying active ingredients, excipients, or delivery mechanisms outside the claim scope, competitors may design around the patent.
4. Is DK1863487 enforceable outside Denmark?
Protection extends only within Denmark; for international protection, corresponding patents in other jurisdictions are necessary.
5. What are the main risks to DK1863487’s patent protection?
Prior art that discloses similar formulations or methods, lack of inventive step, or failure to maintain and enforce the patent.
References
[1] European Patent Office. "European Patent Database," 2023.
[2] World Intellectual Property Organization. "Patent Landscape Reports," 2022.
[3] Patent information on DK1863487, available from Danish Patent and Trademark Office records.
[4] Specific prior art documents cited during patent examination, accessible through patent office files.
