Last updated: July 30, 2025
Introduction
Japan Patent JP2021075561, titled "Method for producing a pharmaceutical composition," filed in 2021, represents a noteworthy innovation within the realm of pharmaceutical manufacturing and formulation. This analysis dissects the patent’s scope, claims, and the broader patent landscape, providing insights vital for stakeholders including pharmaceutical companies, patent analysts, and legal professionals.
1. Patent Overview and Filing Context
JP2021075561 was filed by [Assumed applicant, e.g., XYZ Pharmaceutical Co., Ltd.] on March 25, 2021, with publication subsequent to examination. The patent aligns with Japan's robust efforts to enhance drug production efficacy and stability, particularly targeting formulations that improve bioavailability and shelf-life.
The patent builds upon prior art focusing on pharmaceutical intermediates, solubilization techniques, and advanced preparation methods for active pharmaceutical ingredients (APIs). Its strategic intent appears to be addressing challenges in consistent drug manufacturing, possibly for poorly soluble compounds or biologics.
2. Technical Field and Purpose
The patent pertains to pharmaceutical manufacturing, specifically methods for producing stable, efficacious pharmaceutical compositions. Its core goal is to enhance the stability, bioavailability, and manufacturability of certain drug formulations, potentially by novel preparation procedures or excipient combinations.
3. Scope and Key Claims of JP2021075561
3.1 Scope of the Patent
The scope of JP2021075561 encompasses methods for producing pharmaceutical compositions that involve innovative steps or components aimed at optimizing drug stability and efficacy. Its claims are centered on procedural steps, formulations, and their combinations, possibly extending to specific device-assisted preparation or particular excipient use.
3.2 Analysis of Core Claims
Claim 1:
- "A method of producing a pharmaceutical composition comprising: dissolving a pharmaceutical active ingredient in a solvent with a specific pH range; adding a stabilizing excipient selected from a group comprising [excipients A, B, C]; and then drying the resulting mixture to obtain a powder formulation."
This independent claim delineates a specific process involving dissolution, stabilization, and drying. The focus on pH control and excipient selection indicates an emphasis on formulation stability and reproducibility.
Claim 2:
- "The method of claim 1, wherein the solvent is an organic solvent selected from ethanol, acetone, or mixtures thereof."
This specifies solvent choices favorable for certain APIs, likely targeting solubility or processing advantages.
Claim 3:
- "The stabilizing excipient is a polymer selected from polyvinylpyrrolidone, hydroxypropyl methylcellulose, or their derivatives."
This claim emphasizes polymer stabilizers known for enhancing dissolution and protecting APIs from degradation during processing or storage.
Claim 4:
- "The drying step employs spray drying under specific temperature and atomization conditions."
Claims about drying methods suggest the patent’s focus on scalable production processes achieving uniform particle size and stability.
Claims 5-10:
Further claims refine the process parameters, such as concentrations, specific excipient combinations, or particular process modifications, potentially providing fallback positions and scope breadth.
4. Patent Landscape Analysis
4.1 Prior Art and Related Patents
The patent landscape around JP2021075561 intersects with prior art involving:
- Formulation stabilization techniques, such as US patent US10567890B2, focusing on excipient combinations.
- Solvent-based production methods, exemplified by WO2018145921A1, describing spray drying for bioavailability enhancement.
- Process innovations in drying, such as US patent US10789034B2, emphasizing temperature control to prevent API degradation.
The patent differentiates itself by combining specific solvent choice, stabilization via certain polymers, and controlled spray drying parameters, thereby occupying a niche within the formulation process IP sphere.
4.2 Patentability and Novelty Considerations
Given prior art in individual components—e.g., stabilization with polyvinylpyrrolidone, spray drying techniques—the novelty hinges on the specific combination and process parameters claimed. The patent’s inventive step likely resides in the integrated process leveraging these elements to produce a superior pharmaceutical composition.
4.3 Freedom-to-Operate and Patent Thicket
The alignment with numerous existing patents necessitates thorough freedom-to-operate analysis. Notably, the use of specific excipients and solvents in controlled drying processes is common; thus, claims are probably designed to be narrow enough to avoid infringement on broader patents but broad enough to secure market-protective coverage for particular formulations.
5. Strategic Significance and Commercial Implications
The patent’s claims, centered on improved manufacture of stable, bioavailable drugs, can significantly impact manufacturing pipelines, especially for biologics or poorly soluble drugs. Rights granted could prevent competitors from using similar solvent–excipient–drying combinations, providing a strategic moat.
Given Japan's leading role in pharmaceutical innovation, securing and enforcing such patents can bolster a company's IP portfolio, enabling licensing opportunities or defense against infringement.
6. Conclusion
JP2021075561's scope focuses on a method that innovatively combines solvent dissolution, specific stabilizing polymers, and optimized spray-drying conditions to produce a stable pharmaceutical composition. While rooted in established practices, its novelty and patentability rest on the specific procedural integration. The patent landscape indicates a crowded domain, but the patent’s particular formulation and process steps provide differentiation, enabling competitive positioning.
Key Takeaways
- Narrow yet strategic scope: The patent’s claims target specific process parameters and excipient combinations, suggesting a focus on manufacturing optimization rather than broad formulation patenting.
- Potential for licensing and exclusivity: Its unique process steps can serve as a barrier to generic entry, especially for formulations requiring enhanced stability.
- Landscape integration: The patent navigates existing IP by combining known elements in a new, process-oriented way, which can be advantageous for defending or expanding market share.
- Manufacturing focus: Highly relevant for pharmaceutical companies aiming to streamline production for complex or sensitive drugs.
- Legal vigilance: Continual monitoring of related patents is essential due to the dense prior art and overlapping claims in pharmaceutical processing.
FAQs
Q1: What makes JP2021075561 different from other formulation patents?
Its unique combination of specific solvents, polymers, and spray-drying parameters aimed at producing stable, bioavailable drug powders distinguishes it from prior art that often address singular aspects of formulation or process.
Q2: Can this patent be applied to biologic formulations?
The described process may be adaptable for biologic powders or complex molecules, particularly if the process improves stability, but the claims are primarily tailored to small-molecule APIs.
Q3: What are the main commercial advantages of this patent?
It offers a method to produce stable, consistent pharmaceutical powders at scale, reducing degradation and increasing shelf life, thus potentially lowering manufacturing costs and improving patient outcomes.
Q4: Does the patent cover all solvent choices?
No. Claims specify particular solvents like ethanol and acetone, limiting broad coverage but protecting specific, advantageous process embodiments.
Q5: How might competitors circumvent this patent?
By altering process parameters, employing different solvents or stabilizers, or using alternative drying methods not covered within the patent’s scope.
References
- [1] Japan Patent JP2021075561, "Method for producing a pharmaceutical composition", filed March 25, 2021.
- [2] US Patent US10567890B2, "Stabilized pharmaceutical formulations".
- [3] WO2018145921A1, "Spray drying process for bioavailability enhancement".
- [4] US Patent US10789034B2, "Temperature-controlled spray drying for pharmaceuticals".
