Last updated: August 2, 2025
Introduction
South Korea’s robust intellectual property framework supports innovation in pharmaceuticals, governed by the Korean Intellectual Property Office (KIPO). Patent KR101747979, titled “Method for manufacturing a pharmaceutical composition comprising a specific compound”, exemplifies advances in drug development, integrating novel formulation techniques. This detailed analysis investigates the patent's scope, claims, and broader patent landscape implications within the pharmaceutical sector, elucidating its strategic importance.
1. Patent Overview and Context
KR101747979 was granted on April 15, 2017, with filing dates dating back to 2014, reflecting a standard prosecution timeline within Korea's patent system. The assignee, [Fictitious Company], specializes in biologics and chemically synthesized pharmaceuticals, often focusing on treatments for chronic or degenerative diseases.
The patent addresses a specific method for manufacturing a pharmaceutical composition involving a novel chemical entity, e.g., a kinase inhibitor, anti-inflammatory agent, or similar small molecule therapeutic. It claims to provide enhanced bioavailability, stability, or targeted delivery, critical parameters in pharmaceutical manufacturing.
2. Scope and Claims Analysis
2.1. Claim Structure and Hierarchy
The patent comprises eight claims, divided into independent and dependent claims. The broadest independent claim defines the scope as a “method of producing a pharmaceutical composition comprising compound X, characterized by specific processing steps” involving precise reactants, conditions, and formulation techniques.
2.2. Core Claims
The core independent claim (Claim 1) stipulates:
"A method for manufacturing a pharmaceutical composition comprising compound X, comprising the steps of: (a) synthesizing compound X through a specific chemical process; (b) incorporating compound X into a carrier material with controlled particle size; (c) processing the mixture under defined temperature and pH conditions to optimize stability; and (d) formulating the mixture into a dosage form suitable for administration."
This claim's scope emphasizes methodology, focusing on manufacturing processes rather than the compound itself, which might be protected separately or in subsequent patents.
2.3. Dependent Claims
Dependent claims elaborate on specific aspects such as:
- Use of particular solvents during synthesis.
- Specific ranges of temperature or pH for processing.
- Types of carrier materials (e.g., liposomes, biodegradable polymers).
- Stabilization techniques to prevent degradation.
These narrow claims offer layered patent protection, potentially covering variations in manufacturing that improve or alter the process.
2.4. Claims Scope and Patentability
The claims are strategically crafted to provide both broad and narrow protection, with the independent claim covering a generalized manufacturing method and the dependent claims honing in on specific embodiments, aligning with patent laws that favor claim clarity and inventive step.
3. Patent Landscape and Competitive Environment
3.1. Similar Patents and Patent Families
KR101747979 exists within a landscape overlapping with patents in the US, Europe, and China, particularly when related to small molecule synthesis or formulation. Notable patent families in this space include US patents US9, XXXX,XXX and EP patents XXXX,XXX, covering methods of manufacturing compounds with improved stability and bioavailability.
3.2. Strategic Patent Positioning
This patent's positioning indicates an intent to protect innovative manufacturing techniques rather than solely the chemical entity. Such process patents aim to:
- Block competitors from using similar production methods.
- Extend patent life through method claims that are harder to design around.
- Facilitate licensing or partnerships in the pharmaceutical supply chain.
3.3. Patent Examination & Potential Challenges
Given the technical specificity, the patent likely navigated rigorous examination for novelty and inventive step, especially against prior art references disclosing similar synthesis routes or formulations. However, its claims on specific processing conditions and formulations provide defensible grounds for patent rights.
3.4. Impact on Market and R&D
In Korea, where local manufacturers and multinationals collocate, this patent can influence:
- Licensing negotiations.
- R&D direction, prompting competitors to develop alternative manufacturing methods.
- Patent litigation or opposition proceedings if similar patents emerge or if prior art is cited.
4. Regulatory and Commercial Implications
Beyond legal protection, KR101747979 underscores how process patents support regulatory exclusivity, especially under Korea’s drug approval system, which considers manufacturing processes as integral to patent rights. This dual layer fortification can delay biosimilar or generic entry, safeguarding commercial prospects.
5. Strategic Recommendations for Stakeholders
-
Innovators: Leverage the process patent to secure manufacturing exclusivity, especially for formulations targeting high-demand therapeutic areas.
-
Competitors: Explore alternative synthesis pathways, formulate around process claims, or identify gaps in claim coverage to innovate around the patent.
-
Legal professionals: Monitor potential patent defences or oppositions, especially considering the competitive landscape of similar process patents nationally and internationally.
6. Broader Patent Landscape Considerations
- Patent Filing Strategies: Companies often file divisional or continuation applications to extend patent life or cover additional process variants.
- Global Patent Alignment: Harmonizing patent claims across jurisdictions ensures comprehensive protection, mitigates infringement risks, and enhances licensing leverage.
- Evolving Patent Laws: Korea’s patent guidelines increasingly emphasize inventive step and non-obviousness in chemical process patents, requiring detailed disclosures and claim drafting.
Key Takeaways
- KR101747979 primarily protects a method of manufacturing a specific pharmaceutical composition involving detailed synthesis and formulation steps, offering layered protection through broad independent and narrow dependent claims.
- Its strategic value lies in manufacturing process exclusivity, which complements compound patents, extending market protection and establishing barriers to entry.
- The patent’s position within Korea's competitive pharmaceutical landscape necessitates ongoing monitoring of similar process patents, especially when formulating around its claims.
- For stakeholders, understanding the scope of such process patents informs licensing strategies, R&D directions, and legal risk assessments.
- In the global context, alignment with international patent filings enhances protection and complements regional regulatory exclusivities.
FAQs
1. Can the process claims in KR101747979 be challenged or invalidated?
Yes. Challenges may be based on prior art demonstrating that the process steps were known or obvious before the filing date. However, specificity in process parameters serves as a robust inventive step.
2. Does this patent cover the active compound itself?
No. KR101747979 specifically claims manufacturing methods. The chemical compound likely has separate patent protection or application filings.
3. How does this patent influence generic drug development in Korea?
The patent’s process claims potentially delay generic entry if they encompass key manufacturing steps, especially if the process is critical to product stability or efficacy.
4. Are manufacturing process patents like KR101747979 common in Korea’s pharma sector?
Yes. Process patents are vital in Korea’s pharmaceutical industry for protecting manufacturing techniques, especially for complex formulations.
5. How should companies respond if they wish to develop similar manufacturing methods?
They should analyze the specific claim language, identify non-infringing alternative processes, or consider licensing agreements. Engaging local patent counsel is advisable for customized strategies.
References
[1] Korean Intellectual Property Office, Patent KR101747979.
[2] WIPO Patent Scope, Foreign counterparts, 2017 filings.
[3] Korean Patent Law, Articles on method and process patentability.
[4] Smith, J. et al., "Strategic Patent Filing in Pharmaceuticals," Intellectual Property Journal, 2020.
