Last updated: July 30, 2025
Introduction
Patent KR101495146, titled "Method for Producing a Pharmaceutical Composition", was granted by the Korean Intellectual Property Office (KIPO) and represents a critical intellectual property asset within the pharmaceutical domain. This patent delineates a specific process for manufacturing a pharmaceutical composition, likely aimed at achieving improved efficacy, stability, or manufacturability. Here, we analyze the patent’s scope, claims, and its landscape context within South Korea's competitive pharmaceutical patent environment.
Scope of Patent KR101495146
The scope of a patent defines the extent of legal protection conferred by the patent rights. For KR101495146, the scope primarily revolves around the method of preparing a pharmaceutical composition, emphasizing specific steps, conditions, and components that distinguish this process from prior art.
Core Technical Focus
The patent claims a novel method involving:
- Precise formulation steps,
- Specific temperature and timing parameters,
- Use of particular excipients or carriers,
- Innovative mixing or processing techniques.
This focus aligns with industrial objectives to enhance drug stability, bioavailability, or manufacturing efficiency.
Scope Boundaries
Given the typical structure of such patents, the scope is likely confined to:
- A specific process for producing a pharmaceutical composition;
- Particular combinations of ingredients or carriers;
- Process conditions (e.g., temperature, pH, order of addition).
This specificity limits the patent to processes that adhere to these parameters, providing protection for the claimed method while allowing other manufacturing approaches outside these boundaries.
Potential Limitations
Some limitations include:
- The method’s dependency on particular process steps, which might be circumvented through alternative manufacturing methods.
- The geographical jurisdiction—protection applies solely within South Korea unless extended via filings in other jurisdictions.
In conclusion, the patent’s scope is centered on a refined process for pharmaceutical production, with protective coverage defined by the detailed steps and parameters disclosed.
Claim Analysis
The patent claims form the legal core, dictating the scope of protection. While the full claim set is not provided here, typical claims in such patents fall into independent and dependent categories.
Independent Claims
- Usually, a broad independent claim defines the overall process, e.g., "A method for producing a pharmaceutical composition comprising the steps of...", including specified parameters.
- These claims often encompass a wide range of process variations as long as the core steps are maintained.
Dependent Claims
- Narrower, these specify additional features or limitations, such as particular excipients, temperatures, or order of process steps.
- They serve to further define the invention and provide fallback positions if independent claims are challenged.
Distinctive Claim Elements
- Process Steps: Sequential mixing, heating, cooling, or drying.
- Component Specifics: Use of certain polymers, binders, or solvents.
- Conditions: Precise times, temperatures, or pressure conditions.
Claim Strength and Patentability
- Strong claims directly support the patent’s enforceability.
- Clarity and specificity prevent challenges based on ambiguity.
- The inclusion of novel process features and non-obvious steps supports patent validity.
Potential Substitutions and Workarounds
Third parties may potentially develop alternative processes that avoid infringing the specific claim elements, particularly if the patent’s claims are narrowly tailored.
Patent Landscape within South Korea
KR101495146 is situated within South Korea's vibrant pharmaceutical patent environment, which is characterized by robust innovation, extensive patent filings, and active enforcement.
Historical Context
South Korea has seen exponential growth in pharmaceutical patent filings, especially since the implementation of the Patent Act amendments supporting chemical and pharmaceutical patents. The Korean patent landscape prioritizes clarity and enforceability, emphasizing process patents like KR101495146 to protect manufacturing innovations.
Competitive Landscape
- Major players: Pharmaceutical companies and biotech firms actively file process patents to safeguard manufacturing methods.
- Patent families: Many process-related patents are part of broader patent families, covering formulations, compositions, and manufacturing.
- Patent thickets: Dense clusters of overlapping patents create barriers to entry but foster innovation and licensing opportunities.
Patentability Trends
South Korean patents undergo rigorous examination for novelty, inventive step, and industrial applicability. Process patents such as KR101495146 are favored when they demonstrate non-obvious modifications to existing manufacturing protocols.
Legal and Strategic Considerations
- Freedom-to-operate (FTO) assessments* are crucial when commercializing products involving similar production processes.
- Patent expiry or challenging strategies are common to avoid patent barriers, especially given the extensive patent landscape.
Implications for Commercialization and Innovation
KR101495146's scope indicates significant value in protecting specific process innovations, which can:
- Enhance competitive advantage by preventing imitation.
- Support licensing or partnership opportunities.
- Foster further R&D by providing a solid IP foundation.
However, strategic companies should monitor overlapping patents, evaluate potential workarounds, and consider international filings to expand protection.
Summary of Key Points
- The patent’s scope focuses on a specific process for preparing a pharmaceutical composition with defined process steps and parameters.
- Its claims likely combine broad independent elements with narrower dependent features, aiming to balance enforceability with scope.
- The patent landscape within South Korea emphasizes process patents, with vigorous examination standards favoring novelty and inventive step.
- Maintaining competitive advantage involves active monitoring of the patent environment, considering international filings, and exploring potential workarounds.
Key Takeaways
- Precisely Defined Process Claims: The patent’s strength lies in detailed process steps, providing robust protection if maintained and enforced.
- Landscape Awareness: Companies should conduct comprehensive patent landscape analyses to identify potential infringement risks and licensing opportunities.
- Strategic Patent Filing: To maximize protection, consider international extensions (e.g., PCT filings) and build a family of patents covering various process variations.
- Continual Monitoring: Regularly assess evolving patent rights and new filings within South Korea’s active pharmaceutical patent space.
- Innovation Leverage: Use KR101495146 as a foundation to develop advanced manufacturing techniques, avoiding infringement, or enhancing patent scope.
FAQs
1. What is the primary innovation claimed by KR101495146?
The patent claims a novel method for producing a pharmaceutical composition, emphasizing specific process steps, conditions, and components that distinguish it from prior art.
2. How broad is the patent’s scope, and can it be circumvented?
While the scope covers defined process steps and parameters, third parties can develop alternative methods outside these claims, particularly if they alter key process features or conditions.
3. How does South Korea’s patent landscape impact pharmaceutical process patents like KR101495146?
South Korea's rigorous examination and focus on patent clarity favor process patents with clear inventive steps, fostering a competitive environment that encourages process innovation while posing challenges for infringement.
4. Are there international counterparts to this patent?
Unless the applicant pursued international filings (e.g., via PCT), the protection is limited to South Korea. Similar patents may exist in other jurisdictions, but a separate patent search is necessary for confirmation.
5. What strategies should patent holders consider post-grant?
Patent holders should monitor competitive patents, consider licensing opportunities, extend protection through international filings, and explore process improvements to strengthen patent families.
References:
- Korea Intellectual Property Office (KIPO) Patent Database.
- WIPO. PCT Publications and Patent Landscape Reports.
