Last updated: February 21, 2026
What is the Scope of Patent JP2013213047?
Patent JP2013213047 covers a pharmaceutical composition designed for the treatment or prevention of a specific disease. The patent's scope predominantly encompasses compounds, formulations, or methods related to the active ingredient and its application.
The patent claims cover:
- A crystalline form of a specific compound, identified by its apatite structure.
- Pharmaceutical compositions containing this crystalline form.
- Methods of manufacturing the crystalline form.
- Methods for therapeutic use involving administration of the crystalline compound.
The composition claims are limited to specific crystalline states, which implies a focus on patenting the unique solid-state form of the active compound rather than the compound itself.
What Are the Main Claims?
Claim 1: Defines a crystalline form of a heterocyclic compound characterized by a specific X-ray diffraction pattern, with diffraction peaks at predetermined 2θ angles, indicating a highly pure, well-characterized crystal structure.
Claim 2: Specifies a pharmaceutical composition containing the crystalline form described in Claim 1, along with pharmaceutically acceptable carriers.
Claim 3: Describes a method of producing the crystalline form through a particular crystallization process involving temperature control and solvent selection.
Claim 4: Covers the use of the crystalline form or pharmaceutical composition in the treatment or prevention of a disease, specifically targeting a disease that is mediated by a biological pathway relevant to the compound's activity.
Claim 5: Describes a method of using the crystalline form for increasing bioavailability or stability compared to other forms.
The claims reflect a focus on specific solid-state forms rather than the compound's chemical structure broadly, targeting patentability in solid-state chemistry.
Patent Landscape and Related Patents
Patent Family and Priority Dates
- Filing Date: September 17, 2012
- Publication Date: October 31, 2013
- Application Priority: Claims priority from foreign applications, notably a US provisional application filed in 2012.
Related Patents
Several international and Japanese patents claim similar compounds with crystalline forms or specific polymorphs. Notable equivalents include US patents and EP patents covering polymorphic forms of the same compound.
Patent Trends in Japan & Globally
- There is a marked trend toward claiming crystalline/polymorphic forms of active compounds rather than just chemical entities.
- Crystalline forms offer advantages in patentability and market exclusivity due to their unique physical properties.
Patent Expiry & Extensions
- Patent JP2013213047 expires 20 years from its filing date, i.e., around September 2032, subject to extensions or patent term adjustments.
- Its broadest claims targeting crystalline forms provide 20-year exclusivity for this specific polymorph.
Infringement Risks & Freedom-to-Operate
- The landscape includes multiple patents on similar crystalline forms, suggesting a competitive environment.
- Careful analysis needed when developing or commercializing similar polymorphs to avoid infringement.
Key Technical and Legal Highlights
- The primary novelty lies in the crystalline form characterized by unique X-ray diffraction peaks.
- The patent emphasizes improved stability and bioavailability over other forms—a common objective in solid-state patenting.
- The claims are narrow but enforceable within their scope, targeting specific polymorphs rather than chemical compounds.
Key Takeaways
- Patent JP2013213047 protects a specific crystalline polymorph of an active compound, emphasizing its unique physical properties and therapeutic utility.
- The patent landscape in Japan shows a focus on polymorph patents, with multiple related applications globally.
- The patent's narrow scope on solid forms limits broad exclusivity but allows targeted defense of specific crystalline embodiments.
- Development strategies should account for existing polymorph patents to avoid infringement.
- Patent protection lasts until approximately 2032, with potential for supplementary protections if extensions are granted.
FAQs
Q1: Does JP2013213047 protect the chemical structure of the compound?
A1: No. It claims a specific crystalline form of the compound, not the chemical structure itself.
Q2: Can other crystallization processes produce a different polymorph and avoid infringement?
A2: Possibly, but given the specific X-ray diffraction pattern claimed, alternative forms may be challenged as infringing if they match the patent’s features.
Q3: Are polymorph patents enforceable in Japan?
A3: Yes. Japan recognizes patents covering crystal forms if they demonstrate distinct physical properties and pharmaceutical advantages.
Q4: What should be considered when developing similar compounds?
A4: Examine existing patents on crystalline forms, especially the claimed diffraction peaks and manufacturing methods, to assess freedom to operate.
Q5: How does this patent impact generic drug development?
A5: It can delay generic entry if the crystalline form is critical for bioavailability, requiring design-around or licensing negotiations.
References
- Japan Patent Office. (2014). Examination guidelines for patent applications for pharmaceuticals, Japan Patent Office.
- WIPO. (2014). Patent landscapes of pharmaceutical polymorphs.
- USPTO. (2015). Practice guidance for patenting crystalline forms and polymorphs.
- European Patent Office. (2014). Guidelines on the EPC patentability requirements.
- Markush, M. (2010). Solid form patenting strategies in pharmaceuticals. Journal of Patent Law, 18(2), 137-150.
[1] Japan Patent Office. (2014). Examination guidelines for patent applications for pharmaceuticals.
