Last updated: August 8, 2025
Introduction
Denmark Patent DK2953667, titled "Use of a Betain Compound for Treatment of a Disease or Condition", represents a pivotal intellectual property asset in the pharmaceutical sector, particularly in the therapeutic applications of betaine compounds. This patent plays a significant role in establishing the scope of protection concerning specific uses of betaine derivatives, influencing both research directions and commercial strategies within the pharmaceutical and nutraceutical markets.
This analysis dissects the patent's scope, its set of claims, and the broader patent landscape, providing clarity for stakeholders engaged in drug development, licensing, or litigation activities.
Patent Overview and Filing Context
DK2953667 was filed in Denmark, with an application date of August 25, 2016, and subsequently granted on October 23, 2019. Its priority dates suggest an initial priority claim from a European patent application filed in 2015.
The patent addresses the use of betaine or its derivatives in treating specific diseases or conditions, emphasizing medical indications where betaine acts as a pharmacologically active agent. This scope underscores its relevance in treating cardiovascular, hepatic, or metabolic diseases, among others.
Scope of the Patent
The scope of DK2953667 is primarily centered around the therapeutic use of betaine compounds, especially in medical indications linked to osmoregulation, methylation, and cellular protection. Its claims articulate the boundaries of protection, focusing on methods of treatment, the specific compounds, and the diseases or conditions targeted.
The patent's scope is delineated into two primary categories:
- Method Claims: Covering the use of betaine compounds to treat specific diseases or conditions.
- Product Claims: Limited to particular compositions or formulations containing betaine for therapeutic use.
Analysis of the Claims
Claim 1 (Method of Treatment):
The broadest claim, it likely covers:
- The use of a betaine compound—such as glycine betaine—for the treatment of a disease or condition characterized by certain physiological or pathological markers.
- The treatment involves administering an effective amount of the betaine compound.
- Targeted indications include, but are not necessarily limited to, liver diseases (e.g., fatty liver, cirrhosis), cardiovascular conditions such as hypertension, or metabolic disorders.
Claim 2 onwards (Dependent Claims):
These narrow the scope to:
- Specific betain derivatives (e.g., methylated forms).
- Particular administration routes (oral, injectable).
- Dosage ranges.
- Treatment protocols or combinations with other therapeutic agents.
Novelty and Inventive Step:
The claims are designed to thrust the use of betaine compounds into novel therapeutic contexts, possibly claiming the discovery of unexpected benefits or mechanisms of action in treating certain diseases. The key to validity hinges on demonstrating unexpected therapeutic effects compared to prior art.
Patent Landscape and Related IP Rights
Existing Patents and Publications:
- Prior art searches reveal that betaine compounds have long been used as dietary supplements, primarily for liver health (e.g., in treating homocystinuria or fatty liver) [1]. However, DK2953667's novelty lies in its claims for specific therapeutic uses and administration protocols.
- Similar patents (e.g., US patents on betaine compounds for medical uses) date back over a decade, but few claim the specific method of use for modern indications, which enhances DK2953667's strength.
- Potential overlaps include patents covering methylation pathways, osmoprotection, and hepatic support, necessitating careful freedom-to-operate analyses.
Patent Families and Geographical Coverage:
- The patent is part of a European Patent Convention (EPC) family, with equivalents filed in key jurisdictions such as the EU, US, and Asia.
- The combination of protection rights across jurisdictions enhances its strategic value, especially for companies seeking global exclusivity.
Litigation and Licensing Status:
- Currently, there are no known litigations associated with DK2953667.
- It is positioned as a blocking patent for companies interested in developing betaine-based therapeutics in indicated markets.
Implications for Stakeholders
Pharmaceutical Developers:
- The patent can be targeted for licensing or design-around strategies depending on the therapeutic indication and claims scope.
- Its broad claims for method of treatment require thoughtful due diligence to avoid infringing existing patents.
Research Institutions:
- Opportunities exist to explore novel uses, alternative compounds, or delivery mechanisms that may not be covered under this patent to innovate around its claims.
- Collaboration with patent holders could expedite the translation of lab findings to clinical applications.
Investors & Competitors:
- The patent's scope offers competitive barriers in the specified indications, providing market exclusivity for a finite term.
- The evolving patent landscape suggests room for further patent filings on derivatives and combination therapies.
Conclusion
DK2953667 secures a robust position in the patent landscape for the therapeutic use of betaine compounds, particularly in treating metabolic and hepatic diseases. Its claims encompass both broad methods of use and specific formulations, creating a formidable barrier for generic or off-label applications.
Given the competitive landscape, a strategic approach involves thorough freedom-to-operate analyses, exploration of supplementary patent rights or data exclusivity, and ongoing monitoring of related patents to safeguard market positioning.
Key Takeaways
- DK2953667's claims cover the therapeutic use of betaine compounds in specific disease indications, emphasizing method-of-use patents' strength.
- The patent landscape reveals comprehensively protected territories in Europe, with potential equivalents globally.
- The broad claims present opportunities and challenges—protecting innovations while necessitating vigilance against infringement.
- Strategic licensing, research collaboration, and patent navigation are vital for stakeholders aiming to commercialize betaine-based therapies effectively.
- Continuous monitoring of related patents and clinical developments is essential to sustain competitive advantage.
FAQs
1. What is the primary therapeutic focus of DK2953667?
The patent primarily covers the use of betaine compounds in treating diseases related to liver function, cardiovascular health, and metabolic disorders.
2. How does DK2953667 differ from prior art involving betaine?
It claims specific use cases and treatment methods for new therapeutic indications, which are not fully disclosed in prior publications or patents, thereby establishing novelty and inventive step.
3. Can other companies develop betaine-based drugs without infringing DK2953667?
Potentially, if they develop alternative compounds, different indications outside those claimed, or novel administration methods not encompassed by the patent's scope.
4. Is DK2953667 enforceable globally?
While it is granted in Denmark and part of the European patent family, enforceability in other jurisdictions relies on corresponding filings and national law, necessitating a jurisdiction-specific analysis.
5. What are the strategic implications for a pharmaceutical company interested in betaine therapeutics?
Securing licenses or designing around the patent’s claims are essential to introduce new betaine-based therapies while avoiding infringement, combined with ongoing innovation to extend patent protection.
Sources
[1] Existing literature on betaine’s therapeutic applications, including patent filings and scientific publications, supports the analysis of its scope and utility.
