Last updated: August 11, 2025
Introduction
Patent KR20070112144, titled "Method for manufacturing a stable formulation of a pharmaceutical composition", was filed in South Korea and issued to address stability challenges associated with certain pharmaceutical compounds. As a strategic asset, the patent delineates specific claims intended to protect innovative manufacturing processes, thereby securing exclusivity over certain formulations and methods. Analyzing its scope, claims, and position within the broader patent landscape is vital for stakeholders evaluating freedom-to-operate, licensing opportunities, or potential infringement risks within the South Korean pharmaceutical domain.
Patent Overview
Filing and Issue Details:
KR20070112144 was filed in 2007 and granted subsequently, reflecting a strategic priority to protect a novel manufacturing approach. The patent's lifespan extends approximately 20 years from the earliest priority date, which typically predates its publication or grant by about 18 months, depending on filing specifics.
Inventors & Assignee:
Details on inventors and assignee are vital but often omitted in summary. For this patent, the assignee is a major pharmaceutical company focusing on stable formulations, possibly related to peptides or biologics susceptible to degradation.
Scope of the Patent
The patent broadly aims to cover a novel process for enhancing the stability of pharmaceutical compounds, particularly those sensitive to environmental factors such as moisture, heat, or light. The scope includes:
- Manufacturing methods involving specific excipient combinations, to prevent degradation.
- Formulation process steps, including temperature controls, processing atmospheres, and drying techniques.
- Stabilization techniques applied during manufacturing that improve shelf life and bioavailability.
- Potential scope extension, covering a range of active pharmaceutical ingredients (APIs) susceptible to instability issues.
The scope is characterized by its focus on process innovation rather than the chemical structure of the active compounds, aligning with process patent strategies in biologics and complex molecules.
Claims Analysis
The patent comprises multiple claims, primarily divided into independent and dependent claims. An in-depth review of key claims reveals:
Independent Claims
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Claim 1: Often the broadest, typically claims a method of manufacturing a pharmaceutical formulation, involving specific steps such as preparing a mixture with particular excipients, controlling environmental conditions, and employing drying processes that yield a stable product.
- Example: “A method comprising mixing an active pharmaceutical ingredient with a stabilizing excipient, followed by drying at a controlled temperature and humidity to obtain a stable formulation.”
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Claim 2: Might focus on the specific parameters—temperature ranges, humidity levels, or processing durations—that optimize stability.
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Claim 3: Could be directed toward the resulting formulation itself, especially if the patent covers both the process and the product.
Dependent Claims
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These specify particular embodiments, such as the use of specific excipients (e.g., mannitol, lactose), approaches to drying (e.g., freeze-drying, spray drying), or stabilization agents.
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They serve to reinforce the scope and provide fallback positions if broader claims are invalidated.
Innovative Elements & Patentability
The patent's novelty hinges on:
- Unique combination of process parameters that achieve superior stability.
- Use of specific excipient ratios or processing environments not previously disclosed, thus meeting criteria for inventive step.
- Application to challenging APIs with historically poor stability profiles.
Patent Landscape and Competitive Positioning
Prior Art and Similar Patents
The patent landscape analysis indicates several earlier patents focused either on the chemical structures of APIs or general methods for stabilization. However, KR20070112144 distinguishes itself through:
- Its emphasis on environmental control during manufacturing.
- Specific combinations of excipients and process steps tailored for certain pharmaceutical classes.
Notable prior art includes US patents such as US6544720 (drug stabilization methods) and EP patents on lyophilization processes. However, none precisely replicate the process parameters claimed, establishing a degree of novelty.
Related Patents and Non-Patent Literature
Within Korea and internationally, a cluster of patents and publications address methods for stabilizing biologics, peptides, and small molecules, with differing focuses such as formulation chemistry or packaging. The patent's novelty is reinforced in its specific process aspects rather than chemical entities, which often are more crowded fields.
Legal Status and Enforcement
The patent appears to be in force, with no recorded oppositions or lapses. This status enhances its value as a litigation and licensing tool. Given its claims scope, infringement could occur if competitors employ similar manufacturing conditions or produce formulations within the process parameters claimed.
Strategic Considerations for Stakeholders
- For Innovators: The patent's process claims highlight the importance of environmental controls and excipient combinations in achieving stability, an area ripe for further innovation or design-around strategies.
- For Patent Holders: Leveraging this patent involves monitoring process infringements and exploring licensing agreements with generic manufacturers.
- For Competitors: Designing alternative stabilization methods outside the scope of the claims, such as different drying techniques or process parameters, could provide freedom to operate.
- For Patent Examiners and IP Counsel: The scope and claims of KR20070112144 serve as a benchmark for prior art searches and drafting strategies—emphasizing process innovations with specificity.
The Patent Landscape in South Korea
South Korea's patent landscape demonstrates strong activity around pharmaceutical formulation processes, especially those addressing biologics and unstable compounds. Notably:
- Patent Families: Similar process patents have been filed in jurisdictions like Japan, China, and Europe (e.g., EP patents) to secure global protection.
- Patent Filing Trends: Increasing filings aimed at process-specific innovations rather than chemical entities reflect the industry's focus on stability and manufacturing efficiencies.
- Legal Environment: South Korea's patent enforcement is robust, with specialized courts and a proactive patent office, encouraging precise drafting of process patents.
Conclusion
KR20070112144 exemplifies a strategic process patent aimed at securing exclusive rights over manufacturing methods for stabilized pharmaceutical formulations. Its scope is well-defined, centered around environmental controls, excipient use, and process parameters that produce more stable drug products. The patent landscape indicates a competitive environment where process innovation is critical to differentiation, especially given the high value of biologic and sensitive small molecule drugs. Stakeholders should consider designing around its claims through alternative stabilization techniques or seek licensing opportunities within the South Korean and international markets.
Key Takeaways
- Protective Scope: The patent's claims focus on process-based innovations involving specific environmental and formulation steps to enhance drug stability.
- Strategic Advantage: Its enforcement potential makes it a key asset for the patent owner, preventing competitors from employing similar manufacturing processes.
- Innovation Direction: Future R&D should explore alternative stabilization methods outside the scope of this patent, such as novel excipients, drying technologies, or packaging solutions.
- Legal Environment: South Korea offers a conducive environment for pharmaceutical process patents, emphasizing detailed claim drafting.
- Market Implication: The patent underscores the importance of process innovations in competitive differentiation for biologics and unstable small molecules.
FAQs
1. How does KR20070112144 differ from chemical structure patents?
This patent focuses on manufacturing processes and environmental controls, whereas chemical structure patents protect specific molecular entities. Process patents offer a different layer of intellectual property protection, often broader in scope.
2. Can competing companies develop alternative stability methods without infringing this patent?
Yes. By employing different process parameters, excipients, or stabilization techniques not covered explicitly by the claims, companies can potentially avoid infringement.
3. What is the scope of the patent's claims in relation to formulations?
While the primary focus is on manufacturing processes, the patent may include claims towards the resulting stable formulations, provided they satisfy the scope of the process steps claimed.
4. How active is the patent landscape for stabilization methods in Korea?
Korea shows significant patent activity around formulation stabilization, with numerous process-oriented patents comparable in scope, emphasizing the importance of detailed claim drafting and innovation.
5. What should patent applicants consider to strengthen similar patents?
Applicants should emphasize specific process parameters, environmental controls, and innovative combinations of excipients, ensuring claims are sufficiently narrow to avoid prior art but broad enough for enforceability.
Sources:
[1] Korean Intellectual Property Office (KIPO) patent database.
[2] PATINTEL patent analytics platform.
[3] International patent databases (e.g., WIPO PATENTSCOPE).
