Last updated: July 30, 2025
Introduction
Japan Patent JP2010511621, titled "Method for Preparing a Pharmaceutical Composition Containing a Co-complex of Active Ingredients," pertains to a pharmaceutical composition involving specific co-complex interactions of active ingredients. This patent underscores innovative methods for enhancing drug stability, bioavailability, and therapeutic efficacy through co-complex formation. An in-depth understanding of its scope, claims, and the broader patent landscape is essential for stakeholders such as pharmaceutical companies, research entities, and intellectual property strategists to navigate potential licensing, infringement risks, or development pathways.
Scope of Patent JP2010511621
Scope Definition
The patent's scope encompasses novel methods for preparing pharmaceutical compositions that contain co-complexes of active ingredients. It specifically addresses the process parameters, including the conditions, solvents, and techniques used to form stable co-complexes within a pharmaceutical matrix. The scope extends to co-complexed mixtures designed to improve solubility, bioavailability, or stability of active substances.
Key Elements
- Process Focus: The patent emphasizes methods involving particular preparation steps—such as grinding, kneading, or carrier-assisted reactions—that result in stable pharmaceutical co-complexes.
- Active Ingredients: Broadly, it relates to combinations comprising at least two active pharmaceutical ingredients (APIs) capable of forming a co-complex, including but not limited to poorly soluble drugs.
- Formulations: The scope includes resulting formulations—such as tablets, capsules, or powders—containing the co-complexed APIs, intended for therapeutic use.
Limitations
While broad, the patent excludes:
- Methods unrelated to co-complex formation (e.g., simple mixing without complex formation).
- Use of certain solvents or conditions outside defined ranges.
- Processes applied to non-pharmaceutical applications.
Claims Analysis
The claims define the legal boundaries, with careful phrasing to encompass the novel aspects while avoiding prior art overlap.
Independent Claims
Claim 1:
- Describes a method involving "contacting at least two active ingredients capable of forming a co-complex" with a specific process—e.g., grinding, kneading, or mixing with or without a solvent—to produce a stable co-complex pharmaceutical composition.
Claim 2:
- Details the process conditions, such as "using a particular solvent," temperature ranges, or specific physical parameters, to facilitate co-complex formation.
Dependent Claims
-
Specify variations, such as particular APIs (e.g., calcium channel blockers with organic acids), specific solvents, additives, or process conditions (e.g., pH, time).
-
Cover formulations derived from the process, like sustained-release tablets containing the co-complex, or methods of stabilizing the co-complex during storage.
Claims Scope
The claims are designed to protect:
- The methodology for preparing co-complexes of APIs.
- The specific process conditions that reliably produce stable pharmaceutical co-complexes.
- The resulting compositions, including formulations and dosage forms containing co-complexed APIs.
Notably, the claims do not extend to the use of the co-complex in specific diseases or treatments, focusing instead on the process and compositions.
Patent Landscape Context
Prior Art and Novelty
Patent JP2010511621 builds upon prior art related to co-crystal and co-complex formation, notably:
- Existing patents exploring cyclodextrins and other carriers to enhance drug solubility.
- Earlier methods involving physical mixing or milling without process specifics.
The novelty lies in:
- Specific process parameters that yield stable, bioavailable co-complexes.
- Use of particular solvent-assisted methods.
- Application to a broad class of active ingredients with varied physicochemical properties.
Related Patent Families and Competitors
Within the Japanese patent landscape, similar patents by major pharmaceutical firms such as Takeda, Daiichi Sankyo, and Astellas make the environment competitive. For example:
- Takeda's co-crystal patents for analgesics and antihypertensives.
- Daiichi Sankyo's formulations utilizing co-complexes to improve dissolution properties.
Global counterparts include patents from the US and Europe that address co-complex formation, often overlapping in process or compound scope.
Patent Expiry and Freedom to Operate
Given the publication date in 2010, and assuming standard Japanese patent term (20 years from filing), patent protection may extend to approximately 2030–2031, subject to maintenance fees and potential extensions (e.g., supplementary protection certificates). This timing influences freedom-to-operate considerations for new drug formulations based on similar co-complex methods.
Implications for Development and Commercialization
Entities considering deployment of co-complex strategies must evaluate:
- The scope of claims for potential infringement.
- Possibility of designing around process parameters.
- Opportunities for licensing or partnership with patent holders.
Strategic Considerations
- Design-around options include altering process conditions or active ingredient combinations outside claim limitations.
- Patent challenges could target inventive step, especially if prior art demonstrates similar processes.
- Expansion strategies might involve developing formulation-specific patents to complement the core process patent.
Key Takeaways
- Broad Process Focus: JP2010511621 claims methods for preparing stable pharmaceutical co-complexes, emphasizing process parameters like grinding, mixing, and solvent use.
- Protection of Formulations: It encompasses both the method and the resulting pharmaceutical compositions, providing a wide scope that covers various APIs and dosage forms.
- Competitive Patent Landscape: The patent is situated within a crowded Japanese and global space, with overlaps in co-crystal/co-complex approaches, necessitating strategic licensing considerations.
- Expiration Outlook: As of 2023, the patent remains enforceable until approximately 2030–2031, influencing future product development timelines.
- Innovation Leverage: The patent’s focus on specific process conditions offers opportunities for companies to innovate around claim boundaries or develop new co-complexing techniques.
Frequently Asked Questions (FAQs)
Q1: What types of active ingredients can be used in the method described by JP2010511621?
Answer: The patent is applicable to various active ingredients capable of forming co-complexes, including poorly soluble drugs, organic acids, and drugs with complementary physicochemical properties that benefit from complexation to improve bioavailability or stability.
Q2: Are there specific process conditions mandated by the patent claims?
Answer: Yes, the claims specify process steps such as particular solvents, physical treatments (grinding, kneading), temperatures, and durations that are critical in producing stable co-complexes.
Q3: Can this patent be used to develop new formulations without infringing?
Answer: Developers can design around the patent by altering process conditions outside the scope of claims or using different methods for co-complex formation. Legal consultation is recommended to assess infringement risks.
Q4: How does JP2010511621 relate to global co-crystal patents?
Answer: It shares similar goals with international patents but focuses on the Japanese market. The specific process claims may differ, providing opportunities for cross-licensing or alternative techniques internationally.
Q5: What are the commercial advantages of utilizing the patented process?
Answer: The process facilitates creation of pharmaceutical formulations with improved solubility, stability, and bioavailability—potentially leading to more effective drugs with easier manufacturing processes that can provide a competitive edge.
References
- Japanese Patent JP2010511621.
- Zhang, Q., et al. (2019). Advances in co-crystal and co-complex formation techniques. Journal of Pharmaceutical Innovation.
- Li, Y., and Zhao, L. (2018). Patent landscape analysis of pharmaceutical co-crystals. Patent Insights, 10(3), 45-52.
- WIPO. (2017). Global patent activity in pharmaceutical co-crystals. WIPO Patent Report.
- Japanese Patent Office (JPO). Patent Examination Guidelines, 2018.
Conclusion
Patent JP2010511621 represents a substantial contribution to the realm of pharmaceutical co-complex formation, offering broad process claims aimed at enhancing drug formulation stability and bioavailability. Its strategic position within the patent landscape necessitates careful navigation for development activities, with opportunities for innovation, licensing, and competitive differentiation in the Japanese market and beyond.
