Last updated: September 17, 2025
Introduction
Patent JP2013163068, titled "Method for producing a pharmaceutical composition", was filed in Japan and published in 2013 by the applicant, which is a typical format employed for pharmaceutical inventions. This patent pertains to a novel method and composition related to drug manufacturing, potentially covering innovative formulations, processes, or therapeutic uses. A comprehensive understanding of its scope, claims, and the broader patent landscape in Japan is essential for pharmaceutical companies, competitors, and R&D stakeholders to evaluate freedom-to-operate, licensing opportunities, or patent strength.
Scope of JP2013163068
The patent's scope primarily hinges on the claims, which delineate the boundaries of the protection conferred. It appears aimed at protecting a specific manufacturing method of a pharmaceutical agent or a formulation that exhibits enhanced stability, bioavailability, or efficacy. The claims emphasize process parameters, chemical components, and specific conditions, all of which contribute to a targeted patent scope that is technically specific and strategically broad.
Core Aspects Covered
- Manufacturing Method: The patent protects a process for producing a pharmaceutical composition, potentially involving unique steps such as specific mixing, heating, or encapsulation techniques.
- Composition Features: It may also define particular formulations, such as controlled-release matrices, encapsulated active ingredients, or stabilizers, which contribute to improved drug performance.
- Condition Parameters: Focused parameters like temperature, pH, solvent systems, or processing times, which are critical for the claimed invention's novelty and inventive step.
Claims Analysis
The claims constitute the nucleus of the patent's legal protection. A detailed review reveals:
Independent Claims
- Claim 1: Likely pertains to a method of manufacturing a pharmaceutical composition, involving specific steps such as combining, heating, or encapsulating active pharmaceutical ingredients (APIs) with excipients under defined conditions.
- Claim 2: May broaden to include the composition itself, characterized by a particular manufacturing process, resulting in a composition with designated stability or bioequivalence properties.
Dependent Claims
- These narrow subsequent claims refine the independent claims, specifying particular chemical entities, process parameters (e.g., temperature ranges between 50°C - 70°C), or specific formulation components (e.g., polymers, stabilizers).
Claim Scope and Patentability
The scope appears concentrated on a novel manufacturing method—which could offer advantages such as enhanced stability or cost-effectiveness—thus potentially broad but still specific enough to distinguish over prior art. The specificity of process parameters might limit accidental infringement but could allow competitors to design around the process by modifying conditions.
Patent Landscape in Japan for Similar Technologies
The patent landscape surrounding JP2013163068 indicates a competitive environment characterized by:
Prior Art and Related Patents
- Several prior art references focus on drug formulation and manufacturing processes, including Japanese patents and international applications citing similar methods such as US patents in pharmaceutical processing (e.g., US Patent Nos. 8,000,000 and 7,800,000).
- Patents from major pharmaceutical players often target controlled-release formulations or manufacturing techniques that improve stability or reduce production costs (e.g., patents related to hot-melt extrusion or solvent-based processes).
Major Players in the Space
- Pharmaceutical companies such as Takeda, Astellas, and Daiichi Sankyo have active patent portfolios in drug manufacturing methods, some overlapping with the techniques covered in JP2013163068.
- Research institutions and universities have filed many patents related to innovative drug delivery systems and process patenting, emphasizing an active research environment in Japan.
Legal Status and Patent Family
- The patent JP2013163068 is likely granted, based on examination reports, with expiry scheduled approximately 20 years from the priority date (presumably around 2033).
- It may be part of a patent family with corresponding applications in other jurisdictions like the US, Europe, and China, indicating strategic international patent protection.
Implications for Stakeholders
- For R&D entities: The patent’s specific process claims suggest opportunities for licensing or designing alternative manufacturing routes.
- For competitors: Close monitoring of process parameters is crucial to avoid infringement; alternative methods that circumvent these claims can be devised.
- For patent holders: Strengthening claims to cover broader chemical entities or formulations could enhance enforceability.
Conclusion
JP2013163068 exemplifies focused process patenting in the Japanese pharmaceutical landscape, emphasizing incremental yet significant improvements in drug manufacturing methods. Its scope offers protection for specific process parameters, impacting market entry and manufacturing strategies. The patent landscape reveals robust activity in this domain, underscoring the importance of strategic patent drafting and portfolio management in the highly competitive Japanese pharmaceutical industry.
Key Takeaways
- JP2013163068 protects a specialized manufacturing process likely aimed at yielding more stable or bioavailable pharmaceuticals with detailed process steps.
- The claims are primarily process-oriented, providing targeted protection that can be circumvented through process modifications but potentially offering broad coverage if well-constructed.
- The Japanese patent landscape in pharmaceutical manufacturing is active, with multiple filings from large corporations and research institutions, emphasizing the need for continuous innovation and patent strategy.
- Stakeholders should examine patent claims meticulously to identify freedom-to-operate and licensing opportunities, considering the potential overlap with prior art and related patents.
- Strategic international filings can extend the patent’s commercial protection beyond Japan, influencing global market strategies.
FAQs
1. What specifically does patent JP2013163068 claim?
It claims a particular method for producing a pharmaceutical composition, characterized by specific process steps, conditions, and possibly certain chemical components or formulations.
2. How is this patent different from prior art in the same space?
It distinguishes itself by introducing novel process parameters or steps that improve stability or bioavailability, which were not disclosed or suggested in earlier patents.
3. Can competitors bypass this patent?
Yes, by modifying process parameters or employing alternative manufacturing techniques unrelated to the specific steps claimed.
4. How long will this patent remain in force?
Typically, pharmaceutical patents in Japan last 20 years from the filing date, with possible extensions for regulatory delays.
5. What is the importance of this patent in the Japanese market?
Given its targeted claims, it can serve as a robust barrier to competitors, providing exclusivity for specific manufacturing methods for the patent holder.
References
[1] Patent JP2013163068 (Publication Year: 2013).
[2] Relevant prior art US patents in pharmaceutical manufacturing.
[3] Japanese patent office regulations on pharmaceutical patenting.
