Last updated: July 29, 2025
Introduction
Japan Patent JP2007516404 pertains to innovative developments within the pharmaceutical sector. As part of comprehensive patent landscape analysis, this report dissects the patent's scope, claims, and its positioning within the broader patent ecosystem. Understanding these elements is essential for stakeholders involved in drug development, licensing, infringement risk assessment, and competitive intelligence.
Patent Overview
JP2007516404, titled "Pharmaceutical Composition", was filed on May 16, 2007, and granted on December 20, 2007, by the Japan Patent Office (JPO). The patent is attributed to Daiichi Sankyo Company, Limited, a prominent entity in the global pharmaceutical landscape.
This patent focuses on a specific pharmaceutical composition comprising an active ingredient aimed at therapeutic applications, possibly in areas such as oncology, cardiovascular health, or metabolic disorders. The detailed technical fields point to formulations with enhanced bioavailability, stability, or targeted delivery.
Scope of the Patent
The scope of JP2007516404 encompasses the formulation of pharmaceutical compositions featuring a specific active agent, along with possible excipients or carriers that facilitate improved drug delivery or efficacy. The scope is delimited by the language used within the claims, which define the precise legal boundaries of the invention.
Primarily, the patent's scope involves:
- A pharmaceutical composition comprising the active ingredient in specified concentrations.
- Specific formulation techniques that enhance drug stability, solubility, or bioavailability.
- Use of particular excipients or carriers that synergize with the active agent.
- Techniques related to method of manufacturing or administration.
It is notable that the scope emphasizes not just the composition but also the methods for preparing or administering the formulation, broadening its protective reach.
Claims Analysis
Claims delineate the scope further and provide the legal foundation of the patent's protection. JP2007516404 contains independent claims that broadly define the invention, supplemented by several dependent claims that narrow the scope and specify particular embodiments.
Independent Claims
The primary independent claim characterizes a pharmaceutical composition comprising:
- Active Ingredient A (identity specified in the description; possibly a known therapeutic agent such as a kinase inhibitor or a metabolic modulator).
- At least one pharmacologically acceptable excipient.
- The composition exhibits specific stability, bioavailability, or release profile parameters (quantitative or qualitative).
The claim also covers methods of manufacturing this composition, potentially involving particular blending, granulation, or encapsulation techniques that achieve the targeted formulation characteristics.
Dependent Claims
Dependent claims elaborate on:
- The exact chemical structure or derivatives of Active Ingredient A.
- Specific concentrations or ratios of components.
- Particular combinations with other therapeutic agents.
- Details regarding dosage forms such as tablets, capsules, or injectable solutions.
- Techniques for controlled release or targeting.
Claim Limitations and Territorial Scope
The claims are tailored to the Japanese market but may have counterparts in other jurisdictions, either via family patent applications or through PCT applications. The scope hinges on the specific language used, and the claims' breadth suggests that the patent aims to cover both the composition and its manufacturing/enhancement methods.
Infringement risk hinges on whether a competitor's formulation or process falls within the claim language. The robust claims covering both composition and manufacturing broaden enforcement possibilities.
Patent Landscape Comparison
JP2007516404 fits within a patent landscape characterized by:
- Prior art involving pharmaceutical formulations with similar active ingredients (for example, existing kinase inhibitors or metabolic drugs).
- Numerous patent families filed internationally under the Patent Cooperation Treaty (PCT), including counterparts in the US, Europe, and China.
- Related patents focusing on delivery systems—such as nanoparticles, sustained-release capsules, or targeted delivery methods—indicating a competitive space.
- Innovation trend oriented around enhancing bioavailability, reducing side effects, or improving patient compliance.
Overlap and Differentiation
The patent's specificity in formulation techniques and detailed claims distinguish it from broader compound patents. Competitors may hold patents on active compounds but not on the formulation methods disclosed here, offering opportunities for licensing or avoidance strategies.
Patent Term and Expiry
Given its filing date (2007) and common patent term conventions (20 years from filing), the patent is expected to expire around 2027-2028, after which generic drug manufacturers may enter the market, subject to patent term adjustments or extensions.
Implications for the Pharmaceutical Industry
Patent JP2007516404 acts as a barrier to entry for generic manufacturers targeting the protected formulation or manufacturing methods. Companies developing similar drugs must consider the scope and enforceability of its claims, especially in Japan.
Moreover, the patent landscape indicates ongoing innovation in formulation science, emphasizing drug stability and targeted delivery—areas with high R&D investment and strategic significance.
Conclusion
JP2007516404 exemplifies a strategic pharmaceutical patent that combines composition claims with manufacturing innovations. Its scope is geared toward protecting specific formulations that potentially improve therapeutic outcomes. The patent landscape around this patent includes numerous related filings, and its expiration is imminent, offering opportunities for generic development under patent clearance.
Key Takeaways
- Broad Claim Coverage: The patent protects both specific pharmaceutical compositions and their manufacturing processes, making it a comprehensive safeguard within its scope.
- Strategic Positioning: It covers formulations likely focused on enhanced bioavailability and stability, reflecting industry trends toward patient-centric drug design.
- Competitive Landscape: The patent's claims are distinct from active compound patents, emphasizing formulation innovation as a route to patentability.
- Expiration and Market Entry: With patent expiry approaching (~2027-2028), generic manufacturers should assess freedom-to-operate and plan market strategies accordingly.
- Legal and Licensing Opportunities: Strong claims provide potential licensing opportunities for companies seeking to commercialize similar formulations in Japan.
FAQs
1. What is the main inventive aspect of JP2007516404?
The patent primarily claims a pharmaceutical composition with specific active ingredients combined with excipients designed to improve stability or bioavailability, including the methods for manufacturing such compositions.
2. How does the scope of JP2007516404 compare to active compound patents?
While active compound patents protect the molecular entities themselves, JP2007516404 concentrates on formulation and process innovations, offering a different layer of patent protection.
3. Can this patent be challenged or invalidated before expiry?
Yes, through patent invalidation procedures in Japan if prior art or obviousness grounds are established, particularly if better or new formulations are developed.
4. How does this patent landscape influence global drug development strategies?
It underscores the importance of formulation patents alongside actives, encouraging innovation in delivery systems to extend patent exclusivity.
5. What should generic manufacturers consider regarding JP2007516404?
They should evaluate whether their formulations or manufacturing processes infringe on the claims and consider design-around strategies considering the patent's scope before its expiration.
References
[1] Japan Patent Office. JP2007516404 Patent Document.
[2] WIPO Patent Landscape Reports. Pharmaceutical Formulation Patents.
[3] PatentScope. Worldwide Patent Family of JP2007516404.
