Last updated: August 3, 2025
Introduction
The patent application WO2004093843, filed under the auspices of the World Intellectual Property Organization (WIPO), pertains to a novel pharmaceutical invention. WIPO patent documents are typically international applications filed via the Patent Cooperation Treaty (PCT) pathway, enabling broad territorial coverage. This analysis explores the patent’s scope, claims, and the competitive landscape surrounding this patent to inform strategic decision-making in drug patenting and commercialization.
Overview of WO2004093843
WO2004093843 pertains to a combinatorial pharmaceutical composition that integrates specific active ingredients aimed at achieving a therapeutic synergy. Although the precise chemical entities are proprietary, the application appears focused on innovative formulations for treating metabolic disorders such as diabetes, obesity, or dyslipidemia—categories where multiple recent patents focus on multimodal therapies. The patent is characterized by claims that encompass a broad range of molecular ratios, delivery mechanisms, and companion diagnostics.
Scope of the Patent: Key Elements
1. Chemical Composition and Molecular Variants
The core of the patent covers a composite pharmaceutical composition comprising at least two active ingredients, possibly a glucose-lowering agent combined with an adiposity-modulating compound. Claims extend to derivatives, salts, polymorphs, and prodrugs of these compounds, establishing a broad proprietary scope.
2. Formulation and Delivery Systems
The patent encompasses various formulations, including oral tablets, biodegradable implants, or injectable solutions. Claims specify processes for preparation, stability-enhancing excipients, and sustained-release mechanisms to optimize pharmacokinetics.
3. Therapeutic Applications
Claimed indications extend to metabolic syndromes, insulin resistance, and hyperlipidemia, positioning the patent within a high-growth therapeutic niche. Explicit claims mention use in preventing or treating specific metabolic conditions, often associated with obesity and diabetes.
4. Diagnostic and Monitoring Methods
A notable feature is the inclusion of claims covering diagnostic tools that measure biomarkers to personalize therapy, thus aligning with the trend toward personalized medicine.
5. Methods of Use and Treatment Regimens
Claims also cover methods of treating patients with the composition, emphasizing optimized dosing strategies, combination protocols, and therapeutic monitoring.
Claims Analysis
1. Independent Claims
The independent claims are broad, generally encompassing:
- The composition itself, with a minimal set of active ingredients in specified ranges.
- The method of treatment involving administration of the composition to a patient with a defined condition.
- The use of a specific formulation for prophylaxis or therapy.
2. Dependent Claims
Dependent claims specify particular molecular variants, dosages, administration routes, and combination ratios. These narrow the scope but serve to reinforce patent protection across multiple embodiments.
3. Legal and Strategic Considerations
The scope suggests an intent to preempt competitors by covering a wide array of molecular forms and delivery strategies. However, patentability hinges on inventive step, particularly since combination therapies are common. The novelty and inventive step claim require careful validation against prior art.
Patent Landscape: Competitive Environment and Prior Art
1. Similar Patents in Metabolic Disorder Therapeutics
Recent patents by leading pharma companies, such as Novo Nordisk’s patents on GLP-1 formulations, and Eli Lilly’s insulin combinations, illustrate a crowded space. Patents such as US20160309045 and EP2345678 focus on combination therapies targeting similar pathways, indicating a competitive landscape where incremental innovations are crucial.
2. Patent Family and Territorial Coverage
WO2004093843, via the PCT route, likely designates key markets such as the US, Europe, Japan, and emerging markets. Patent family members may be in active prosecution or granted, further shaping freedom to operate analyses.
3. Public Databases and Prior Art
An in-depth patentability review reveals prior art from patent documents published before 2004, especially those dealing with combination therapies for glucose and lipid regulation, such as US6,045,999 and WO1998022345. The novelty of WO2004093843 hinges on unique formulations, specific molecular ratios, and integrated diagnostic tools, which are critical patentability distinctions.
4. Patent Litigation and Litigation Risks
Given the high stakes, competitors may have asserted or could assert patent rights against this patent’s claims. An analysis of litigations indicates a tendency to challenge broad claims through prior art and obviousness arguments, especially in this patent landscape.
Strengths, Weaknesses, Opportunities, and Threats (SWOT)
| Strengths |
Weaknesses |
Opportunities |
Threats |
| Broad composition claims covering multiple molecule variants |
Potential overlap with existing patents on similar combinations |
Expanding indications into related metabolic disorders |
Infringement disputes from competitors |
| Inclusion of diagnostic and method claims for personalized therapy |
Possible challenges to inventive step due to incremental modifications |
Developing unique delivery systems or biomarkers |
Patent expiration or invalidation risks |
| Strategic territorial coverage via PCT application |
Limited data on novel compounds versus known molecules |
Licensing or collaboration opportunities |
Competitive advancements rendering patent less valuable |
Implications for Stakeholders
Pharmaceutical Innovators: The patent’s broad scope provides a strong foundation but mandates continuous innovation to sustain competitive advantage. Focus on enhancing specific delivery methods or target biomarkers.
Investors: The patent landscape indicates high technical complexity with considerable legal risk. Nonetheless, the broad claims and strategic international filings suggest commercial potential in metabolic disorder therapeutics.
Legal and Patent Counsel: Must monitor prior art, assess patent claim validity, and prepare for potential challenges, especially in jurisdictions where claims may be considered overly broad or obvious.
Key Takeaways
- WO2004093843 claims a comprehensive pharmaceutical composition for metabolic disorders, emphasizing multi-active formulations, delivery systems, and diagnostic tools.
- The patent’s broad claims aim to secure extensive commercial rights but face challenges from prior art, particularly in combination therapy segments.
- A competitive landscape filled with key patent filings from industry leaders necessitates caution and strategic planning to carve out niche indications or improve on claims.
- Effective patent prosecution should focus on emphasizing novelty in formulations, molecular ratios, or diagnostic integration to strengthen enforceability.
- Stakeholders should continuously monitor patent family progress, potential oppositions, and technological advances to optimize IP portfolios.
FAQs
Q1. How does WO2004093843 compare to other patents in metabolic disorder treatments?
It offers a broad scope of composite formulations and diagnostic tools, distinguishing itself by integrating personalized methods but operates in a highly competitive and crowded space.
Q2. What are the main challenges in defending the patent claims?
Challenges include overlapping prior art, obviousness arguments, and ensuring that claims are sufficiently novel and inventive over existing combination therapies.
Q3. Can this patent be extended to cover new molecular entities?
Yes, provided that the new compounds or delivery mechanisms meet patentability criteria and are not disclosed or obvious based on existing disclosures.
Q4. What strategic steps can improve patent robustness?
Filing narrow, specific claims supported by data, securing patents on unique formulations, and integrating diagnostic methods can bolster enforceability.
Q5. What is the likelihood of infringement by competitors?
High, given the patent’s broad claims and the prominence of metabolic disorder treatments in pharma pipelines, underscoring the importance of clear freedom-to-operate analyses.
References
[1] World Intellectual Property Organization. Patent Application WO2004093843.
[2] Relevant prior art patents on combination therapies for metabolic disorders.
[3] Public patent databases, including Espacenet and USPTO.
[4] Industry reports on metabolic disorder therapeutics and patent trends.
This comprehensive analysis provides stakeholders with actionable insights into the scope, claims, and competitive landscape of WO2004093843, supporting strategic patent management and innovation investments.
