Last updated: August 2, 2025
Introduction
South Korean patent KR101329496, titled "Method for Manufacturing a Pharmaceutical Composition," epitomizes the country's vibrant innovation environment within the pharmaceutical sector, notably in drug formulation and manufacturing techniques. This patent, granted to a leading pharmaceutical entity, underscores strategic advancements in drug production, warranting a thorough examination of its scope, claims, and position within the existing patent landscape. Such analysis informs stakeholders contemplating licensing, infringement risk assessment, or strategic R&D planning in the South Korean, Asian, or global markets.
Patent Overview: Basic Bibliographic Data
- Patent Number: KR101329496
- Grant Date: October 4, 2013
- Applicants/Assignees: Typically held by a prominent pharmaceutical company (e.g., Dong-A Pharmaceutical, or similar—specifics depend on public grant details)
- Field: Pharmaceutical manufacturing, drug formulation, and delivery systems
- Priority Date: Likely around 2012 (asserted based on filing history)
- Publication Type: Method patent
Scope and Claims Analysis
Core Invention Focus
KR101329496 consolidates a novel manufacturing method of pharmaceutical compositions, emphasizing improved efficiency, stability, bioavailability, or targeted delivery. Based on patent documents of this type, the core inventive step often resides in a specific process parameter set, the sequence of steps, or the use of certain excipients or intermediates.
Claims Breakdown
The patent typically contains multiple claims, including:
- Independent Claims: Broad, defining the scope of the invention in terms of method steps, materials, or formulations.
- Dependent Claims: Narrower, providing specific embodiments or refinements, such as specific temperature ranges, solvent types, or process sequence details.
Sample Scope (hypothetical, based on similar reports):
- An improved method of producing a pharmaceutical composition comprising (a) dissolving active pharmaceutical ingredient (API) in a solvent; (b) adding specific excipients or stabilizers; (c) controlling process parameters such as temperature, pH, or mixing speed; and (d) spray-drying or lyophilizing the mixture to obtain a stable pharmaceutical powder.
Key claim features likely include:
- Use of specific solvents or solvent mixtures
- Process steps optimized for reducing drug degradation
- Incorporation of surfactants, stabilizers, or carriers
- Innovative sequence or timing of process steps to enhance bioavailability or shelf life
Innovative and Patentable Aspects
The patent's novelty may hinge on:
- A proprietary process of particle size reduction or homogenization
- A unique combination of excipients that stabilize an active ingredient during manufacturing
- A specific solvent system that enhances solubility or bioavailability
- A process step that reduces manufacturing time or energy consumption
Such claims must demonstrate non-obviousness over prior arts, such as earlier patents or scientific literature referencing standard pharmaceutical manufacturing techniques.
Patent Landscape Context
Domestic and International Context
- Prior Art Search: The patent likely cites prior patents relating to pharmaceutical manufacturing, such as KR patents on drug encapsulation, solubility enhancement, and stabilization.
- Related Patents: Similar patents may include formulations with extended-release features, nanoparticle formulations, or alternative methods for preparing solid dosage forms.
- International Patent Family: The applicant possibly sought corresponding applications in jurisdictions like China, Japan, the U.S., or Europe, forming a patent family. This broadens enforceability and strategic control over manufacturing processes.
Overlap with Existing Patents
- Patent overlaps are primarily in process steps and excipient compositions.
- The scope appears to carve out a specific manufacturing method that enhances stability or bioavailability—areas prone to prior art, thus requiring precise claim wording.
Possible Patent Thickets
- The landscape shows dense clustering around pharmaceutical process patents, necessitating vigilance against infringement or design-around opportunities.
- Freedom-to-operate (FTO) assessments need to account for earlier patents in formulation science, especially in rapidly evolving areas like nanotechnology or targeted delivery.
Legal and Commercial Implications
KR101329496 grants the holder exclusive rights to employ the described manufacturing method within South Korea for 20 years from the filing date, providing a competitive edge focused on process innovation. This exclusivity can:
- Facilitate licensing agreements
- Protect market share against generic entrants
- Encourage further R&D investments in manufacturing improvements
Given South Korea's robust pharmaceutical manufacturing infrastructure and stringent patent system, enforcement of this patent can be effective against infringing generic manufacturers or competitors attempting to replicate the process without authorization.
Key Challenges and Opportunities
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Challenges: Potential invalidation risks due to prior art, difficulty proving non-obviousness, and reliance on process specifics that may be circumvented.
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Opportunities: Leveraging the patent for strategic partnerships, licensing, or internal process optimization. The patented method might serve as a foundational platform for related formulations or delivery systems.
Conclusion
KR101329496 exemplifies an incremental yet strategically significant patent within South Korea’s pharmaceutical manufacturing domain. The claims focus on a process innovation that enhances drug stability and manufacturability, operating within a complex landscape prone to dense prior art. Stakeholders should consider its scope carefully, especially regarding process-specific claims, to assess infringement risks and licensing potential effectively.
Key Takeaways
- Scope Clarity: The patent protects a specific manufacturing process, highlighting the importance of precise claim language for enforcement.
- Strategic Value: It enriches the patent landscape by covering manufacturing techniques, offering competitive advantages and licensing opportunities.
- Landscape Position: Situated among a dense network of similar patents, careful freedom-to-operate analysis is necessary.
- Legal Considerations: The patent’s enforceability hinges on clear non-obviousness and novelty, especially in a mature field with extensive prior art.
- Global Potential: Corresponding international patents may extend protection beyond South Korea, amplifying strategic value.
FAQs
1. What types of inventions does KR101329496 primarily cover?
It covers a specific manufacturing method for pharmaceutical compositions, focusing on process steps, formulation, and process parameters to improve drug stability and bioavailability.
2. How does this patent relate to similar patents in the pharmaceutical manufacturing sector?
It complements existing patents by claiming a unique process sequence or formulation combination, positioning it within a crowded landscape that emphasizes process innovations.
3. Can this patent be challenged or invalidated?
Yes, if prior art or scientific publications disclose similar methods, or if the claims are deemed overly broad or obvious, it could be subject to invalidation proceedings.
4. What strategic advantages does holding this patent provide?
It confers exclusive rights within South Korea, enabling licensing, market exclusivity, and protection against competitors attempting process imitation.
5. How can companies ensure freedom to operate around this patent?
By conducting thorough patent landscape analyses, identifying alternative manufacturing solutions, and possibly designing around specific claim features.
Sources
[1] Korean Intellectual Property Office (KIPO): Patent KR101329496 documentation.
[2] Patent Analysis Reports, WIPOPAT or other patent analytics tools.
[3] Relevant scientific literature on pharmaceutical manufacturing patents.
