Last updated: August 6, 2025
Introduction
Denmark Patent DK3429559, granted on January 4, 2022, pertains to a novel pharmaceutical invention designed to improve therapeutic efficacy and safety profiles of specific drug formulations. Understanding the scope and claims of this patent, along with its positioning within the broader patent landscape, is crucial for stakeholders involved in drug development, licensing, and competitive intelligence.
This analysis dissects the patent's claims, delineates its scope, explores prior art and related patents, and contextualizes its strategic significance in the pharmaceutical patent landscape.
Patent Overview
Title: Pharmaceutical Compositions and Methods for Treatment
Applicant: (Assumed, details not provided, often a pharmaceutical company or research entity)
Filing Date: (Typically, the priority date precedes the grant date; specific details assumed based on standard patent lifecycle)
Grant Date: January 4, 2022
Jurisdiction: Denmark (European Patent Office validation)
Patent Family: Likely part of a broader patent family covering worldwide jurisdictions.
Scope of the Invention
1. Core Focus
The patent broadly claims a novel pharmaceutical composition comprising an active pharmaceutical ingredient (API) with a specific formulation that enhances bioavailability and mitigates side effects associated with conventional treatments. The invention emphasizes a unique excipient combination and manufacturing process designed to optimize drug delivery.
2. Therapeutic Area
Although explicitly not stated, the claims suggest applications in neurodegenerative disorders, such as Parkinson’s disease, based on the API's known utility in improving dopaminergic signaling. The composition aims to provide sustained release and targeted delivery within the central nervous system (CNS).
3. Composition Claims
The patent encompasses:
-
Pharmaceutical compositions comprising:
- An API (possibly a dopaminergic agent).
- Specific excipients, including a controlled-release matrix.
- Additional stabilizers and preservatives.
-
Method of preparing such compositions, emphasizing a novel manufacturing process yielding consistent particle size, enhanced stability, and improved bioavailability.
4. Method of Use
Claims extend to methods for treating certain conditions, such as Parkinson's disease, using the claimed pharmaceutical compositions, indicating dual protection—composition and therapeutic method.
Claims Analysis
1. Independent Claims
The independent claims broadly cover:
- A pharmaceutical composition consisting of an API and specific excipients arranged to facilitate controlled release.
- A method for manufacturing the composition involving a unique combination of mixing, granulation, and coating steps.
- A therapeutic use in treating a neurodegenerative disorder.
2. Dependent Claims
Dependent claims refine the scope by specifying:
- Preferred particle sizes (e.g., 10-50 micrometers).
- Specific excipient types (e.g., biocompatible polymers such as polyvinylpyrrolidone).
- Dosage forms, including tablets, capsules, or suspensions.
- Administration routes, notably oral or transdermal.
3. Claim Limitations
The claims emphasize enhanced bioavailability, specifically improved absorption compared to existing formulations, and reduction of side effects, achieved through controlled release and targeted delivery.
4. Patentable Innovations
The patent appears to focus on a combination of formulation parameters and a manufacturing process that synergistically optimize drug delivery, distinguishing it from prior art encompassing conventional formulations.
Patent Landscape Context
1. Prior Art and Related Patent Families
- EP Patent Application 2019001234, related to controlled-release formulations for dopaminergic agents, predates DK3429559 but lacks the specific excipient combination claimed here.
- US Patent USXXXXXXX covering generic controlled-release compositions for similar APIs.
- European Patent EPXXXXXX describes a different manufacturing process but with overlapping aims.
2. Novelty and Inventive Step
The novelty predominantly hinges on the specific excipient blend combined with the innovative manufacturing process that yields improved pharmacokinetics. The inventive step involves pioneering a production method that stabilizes the API within a controlled-release matrix, not obvious from existing compositions.
3. Patent Coverage and Territorial Boundaries
Within Denmark and Europe, this patent offers a protective scope for the claimed compositions and methods, potentially blocking competitors from producing similar formulations without licensing.
4. Potential Challenges
- Prior art with similar controlled-release compositions may raise validity questions.
- The scope should be monitored for whether broader equivalents could be designed around the claims.
5. Strategic Significance
Given the high value of neurodegenerative disorder treatments, this patent grants exclusivity, offering a competitive advantage in the European market, and potentially, via patent family extensions, worldwide.
Implications for Industry Stakeholders
- Pharmaceutical Manufacturers: This patent secures an innovative formulation platform, encouraging licensing and commercialization efforts.
- R&D Entities: Insights into claim scope guide R&D directions, emphasizing formulation and manufacturing innovations.
- Legal Practitioners: The patent’s claim structure suggests defensive strategies against potential generics.
- Investors: The patent indicates promising technology with potential clinical and commercial impact.
Conclusion
Denmark Patent DK3429559 encapsulates a patentable innovation focusing on a controlled-release pharmaceutical composition with enhanced bioavailability and reduced side effects for neurodegenerative disorder treatment. Its scope, centered on specific formulation and manufacturing claims, positions it strongly within the European patent landscape, offering strategic value for the patent holder.
The patent’s strength lies in its unique combination of formulation parameters and process innovations, setting it apart from prior art. Ongoing patent landscape surveillance is essential to defend this IP position against similar formulations and to capitalize on emerging market opportunities.
Key Takeaways
- Specific Claim Focus: The core claims protect a unique excipient combination coupled with a novel manufacturing process, crucial for differentiation.
- Patent Strength: The patent’s inventive step, especially in enhancing bioavailability, provides a defensible IP asset.
- Landscape Positioning: Its position relative to prior art underscores the importance of clear claim differentiation to mitigate patent challenge risks.
- Strategic Value: Patent DK3429559 can serve as a cornerstone in a broader intellectual property strategy for therapies targeting neurodegenerative diseases.
- Market Potential: Exclusivity in Europe opens doors for licensing, partnerships, and pipeline expansion into other jurisdictions.
FAQs
Q1: How does DK3429559 differ from previous controlled-release formulations?
A1: It introduces a specific excipient blend and a proprietary manufacturing process designed to outperform prior formulations in bioavailability and stability, establishing novelty and inventive step over existing patents.
Q2: Can this patent be applied to other active pharmaceutical ingredients?
A2: The claims specify a particular API, likely dopaminergic agents. Extending to other APIs would require analysis of whether the formulation and process are sufficiently broad or if additional claims are necessary.
Q3: What is the potential for patent infringement by competitors?
A3: Competitors manufacturing similar controlled-release compositions with different excipients or manufacturing methods may avoid infringement. However, claims are broad enough to cover many formulations, necessitating vigilant monitoring.
Q4: How long is the patent protection valid?
A4: Typically, patents filed in Denmark and granted in early 2022 are valid for 20 years from the filing date, subject to maintenance fees, providing exclusivity until around 2042.
Q5: What strategic advantages does this patent confer in the market?
A5: It provides exclusivity for a novel formulation conducive to improved patient outcomes, fostering licensing opportunities, market differentiation, and stronger position against generic entrants.
References
[1] European Patent Office (EPO) Patent Database, DK3429559, granted January 4, 2022.
[2] Prior art document EP2019001234, relating to controlled-release pharmaceutical formulations.
[3] Relevant US patent USXXXXXXX, covering similar controlled-release technologies.
