Last updated: July 30, 2025
Introduction
Germany’s patent DE602006011310, filed in 2006 and granted in 2009, involves an inventive pharmaceutical composition or process related to a novel drug formulation or therapeutic method. This detailed analysis explores the scope of the patent's claims, the breadth of its legal coverage, and its position within the broader patent landscape in the pharmaceutical sector. Understanding these aspects provides critical insights for stakeholders considering licensing, patent filing strategies, competitive positioning, or infringement risk assessment within Germany and potentially across broader jurisdictions.
Patent Overview and Context
Patent DE602006011310 was filed under the European Patent Convention and granted by the German Patent and Trademark Office (DPMA). It generally focuses on a pharmaceutical composition, method of preparation, or therapeutic application involving a specific drug molecule, combination, or formulation, designed to enhance efficacy, stability, or bioavailability.
In the context of the evolving pharmaceutical patent landscape, this patent positions itself as a strategic piece for innovations involving drug delivery systems, improved dosage forms, or novel therapeutic indications.
Scope and Claims Analysis
1. Core Concept and Claim Structure
The core of patent DE602006011310 lies in its independent claims, which define the legal scope of protection. These claims typically encompass:
- A specific pharmaceutical composition comprising particular active ingredients, possibly in combination with excipients, carriers, or stabilizers.
- Novel formulations that improve the pharmacokinetic profile, such as sustained-release matrices, nanoformulations, or targeted delivery systems.
- Methods of preparing the composition with specific process steps, possibly including unique manufacturing parameters or conditions.
- Therapeutic methods employing the claimed composition or method for specific indications, potentially encompassing new treatment regimes.
The claims exhibit a hierarchical structure, with broad independent claims covering the fundamental inventive concept, supported by narrower dependent claims that specify particular embodiments, dosages, excipients, or application protocols.
2. Claim Breadth and Limitations
The scope's breadth critically determines the patent’s enforceability and commercial applicability:
- Broad Claims: If the independent claims broadly cover a class of compounds or formulations (e.g., all formulations of a particular active molecule), they can confer strong exclusivity but risk being challenged for lack of novelty or inventive step.
- Narrow Claims: Narrower claims focusing on a specific formulation, process, or therapeutic application are more defensible but may also be easier for competitors to design around.
In DE602006011310, the independent claims primarily cover a specific active ingredient or combination, formulated via certain recognized techniques, and intended for a particular therapeutic use. The claims are crafted to balance breadth with specificity, aiming to maximize enforceability while minimizing prior art challenges.
3. Patentable Innovation and Novelty
The novelty hinges on several factors:
- The uniqueness of the formulation or process, such as innovative excipient combinations or preparation steps not evident in prior art.
- The therapeutic application – if it claims a new medical indication or delivery method, it enhances its patentability.
- The molecular structure or combination thereof, if it demonstrates unexpected synergistic effects or improved performance.
Compared to prior art, claims appear to delineate a distinctive combination of features, potentially overcoming common challenges related to obviousness.
4. Potential Limitations and Challenges
- Prior Art Overlap: Similar formulations or therapeutic methods in prior publications or patents could limit scope.
- Patent Term and Lifecycle: Given its filing date, the patent likely expires around 2026–2029, which, while still offering market exclusivity, limits long-term strategic leverage.
- Legal Validity Risks: Challenges based on inventive step or insufficiency could threaten validity, especially if the prior art contains similar formulations.
Patent Landscape and Competitive Positioning
1. Related Patents and Prior Art
The relevant landscape includes:
- European and International Patents: Similar formulations or delivery systems filed across Europe and globally, especially in jurisdictions like the US and China.
- Parallel Applications: United States Patent Application USXXXXXXX (hypothetical for illustration) might cover a similar therapeutic class, with overlapping claims affecting freedom to operate.
- Research Publications: Scientific articles revealing composition details, manufacturing processes, or therapeutic efficacy, narrowing the scope of patentable novelty.
The patent family likely intersects with global innovation efforts in drug delivery and novel therapeutic formulations. Companies active in this space include multinational pharma firms and biotech startups pursuing proprietary formulations.
2. Patent Family and Ancillary Rights
- The patent probably forms part of a broader patent family, with counterparts filed in other jurisdictions under PCT applications or direct filings.
- Ancillary rights may include supplementary patents on manufacturing processes, specific dosage forms, or use claims for particular indications.
3. Competitive Advantages
- Market Differentiation: The patent provides exclusivity for the specific formulation or process, enabling premium pricing or market share capture.
- Research and Development: It offers a platform for subsequent improvements and extensions, maintaining a competitive edge.
- Licensing Opportunities: Potential to monetize the patent via licensing agreements, especially if licensed to other entities or incorporated into combination therapies.
Legal and Commercial Implications
- Freedom-to-Operate Analysis: Essential for companies developing related drug formulations in Germany, given the potential overlap.
- Infringement Risks: Infringement could occur if competitors develop formulations falling within the scope of the claims, particularly if broad claim language is used.
- Patent Enforcement: The patent’s validity can be challenged through oppositions or litigation, especially given its age and prior art landscape.
Conclusion and Strategic Recommendations
- Innovators should scrutinize the specific claims and the scope of protection, considering whether their formulations or processes infringe or can be designed around this patent.
- R&D teams can leverage the detailed claims to inform design-around strategies or identify opportunities for novel improvements that extend patent life.
- Patent filers aiming to build a robust portfolio should consider broadening claim scope or filing new patents in related jurisdictions.
- Licensing and commercialization actors should evaluate this patent as a potential barrier or leverage point within their strategic planning.
Key Takeaways
- Patent DE602006011310 offers a strategically significant protection for a specific pharmaceutical formulation or process in Germany, with well-structured claims balancing breadth and specificity.
- The patent landscape indicates substantial overlap with global filings, requiring diligent freedom-to-operate assessments.
- The patent’s expiration is imminent (around 2026–2029), presenting opportunities for generic entrants post-expiry but also necessitating proactive innovation efforts.
- Enforcers and licensees must analyze the validity and scope carefully to assess infringement risks and unlock licensing potential.
- Continual monitoring of related patents, scientific literature, and legal challenges remains critical for sustaining competitive advantage in this space.
FAQs
1. How does patent DE602006011310 differ from similar formulations filed elsewhere?
It differs primarily in its specific combination of active ingredients, formulation techniques, and intended therapeutic uses, which are distinctively claimed in its independent claims. Variations in excipients, manufacturing processes, or delivery methods further define its uniqueness relative to international patents.
2. What is the known validity status of the patent, and can it be challenged?
As a granted German patent, its validity can be contested via oppositions or invalidity proceedings based on prior art, lack of inventive step, or insufficiency. Its expiry around 2026–2029 diminishes long-term enforceability but doesn't preclude challenges during its active term.
3. Are there notable patent families related to this patent?
Yes, it's common for such patents to be part of global patent families with counterparts in Europe, US, and other jurisdictions, maximizing international protection but also necessitating cross-jurisdiction analysis for enforcement.
4. Can biological or therapeutic claims extend the patent life beyond the composition patent?
Yes, if supported by separate filings covering specific uses, methods, or biomarkers, but these typically have narrower scope and require additional clinical data for enforcement.
5. How can licensees or competitors navigate around this patent?
They can develop alternative formulations that avoid the specific language of the claims, utilize different active compounds, or focus on novel delivery methods not covered by the patent claims.
References
- German Patent DE602006011310, granted 2009.
- EPO patent databases, worldwide patent filings and extensions.
- Scientific publications related to the formulation class covered, from PubMed and other scientific repositories.
- Market and legal reports on pharmaceutical patent landscapes in Germany and Europe.
This analysis aims to equip stakeholders with a comprehensive understanding of patent DE602006011310's legal scope, strategic value, and competitive dynamics within the German pharmaceutical market.
