Last updated: August 11, 2025
Introduction
The South Korean patent KR101587056, titled "Method for Producing a Pharmaceutical Composition," exemplifies innovative efforts within the pharmaceutical manufacturing sector. This patent pertains to a novel process designed to enhance drug production efficiency, stability, or bioavailability. Analyzing its scope, claims, and the surrounding patent landscape offers valuable insights into how it fits within the broader pharmaceutical patent environment of South Korea and prospects for competitors or licensors.
Scope and Detailed Claims
1. Overview of the Patent Claims
The patent encompasses method claims primarily directed to a specific process for preparing a pharmaceutical composition, along with auxiliary composition claims. Its scope targets the production process, formulation parameters, and potentially the use of specific excipients or intermediates.
The main claim (typically Claim 1) describes a process involving:
- Preparation of a drug substance through a particular chemical or physical process.
- Incorporation of specific excipients or stabilizers—notably, a particular segment of the manufacturing process.
- Control conditions such as temperature, pH, or process steps that lead to enhanced drug stability, bioavailability, or manufacturing efficiency.
Additional dependent claims specify particular process parameters—e.g., type of solvent, optimal temperature ranges, or specific raw materials—which narrow or elaborate the primary process scope.
2. Scope of the Patent
The scope explicitly covers:
- Manufacturing methods for pharmaceutical compositions, focusing on specific process steps, sequence, and conditions.
- Formulation-specific processes, especially modifications leading to improved stability, controlled release, or bioavailability.
- Intermediate or precursor compounds used within the process, if claimed.
The scope employs functional language—such as "comprising," "including," or "consisting of"—which indicates an open claim that may encompass various process variations fitting the described parameters. However, the detailed dependent claims delimit the scope to particular embodiments.
3. Limitations and Exclusions
The patent likely excludes processes or compositions that deviate significantly from the specified parameters—such as alternative solvents or different process sequences—limiting its protection mainly to the described process.
Note: Since patent claims are strategic and often include multiple layers, variations outside the explicitly claimed process, such as alternative manufacturing methods, are generally not infringing, unless they fall under an equivalent process.
Patent Landscape Analysis
1. Patent Family and Filing Strategy
- The patent KR101587056 was filed by a Korean innovator or patent assignee focused on pharmaceutical manufacturing technologies.
- Its filing date aligns approximately with a strategic period for innovation in formulation and process improvements, possibly around late 2010s.
- These process patents are often part of a broader patent family, including counterparts in jurisdictions like the US, EP, and China, targeting global commercial rights.
2. Competitive Landscape
In the South Korean market and globally, process patents like KR101587056 often face competition from:
- Existing process patents covering comparable manufacturing methods.
- Scientific literature describing similar techniques, which could challenge novelty or inventive step.
- Patent applications within the same domain, particularly from major pharmaceutical companies or biotech firms aiming for similar formulations.
Competitors typically seek to design around such patents by:
- Altering process parameters (e.g., solvent types, temperatures).
- Developing alternative manufacturing routes.
- Using different excipients or intermediates.
The patent's scope, therefore, is pivotal in assessing how easily competitors can navigate around it and whether the patent forms a core barrier or a supplementary claim within a patent portfolio.
3. Patent Validity and Challenges
- Validity may be challenged if prior art demonstrates similar processes or formulations.
- The inventive step rests on demonstrating that the process confers unexpected advantages—such as enhanced stability or yield—over known methods.
- Enforcement could be feasible if the patented process is commercially deployed, especially given South Korea’s robust patent enforcement environment.
4. Infringement Risks
Companies employing manufacturing processes similar to those claimed in KR101587056 must evaluate potential infringement risks, especially if process parameters are closely matched, even if not identical. Alternative processes that differ substantially in steps or conditions are less likely to infringe.
Implications for Stakeholders
1. Innovators and Patent Holders
They benefit from understanding the specific process steps protected and can leverage KR101587056 in licensing negotiations or patent litigation. The patent enriches a portfolio securing manufacturing innovations for particular formulations or drug classes.
2. Competitors
Developers seeking to avoid infringement must analyze the claim language meticulously. Identifying process steps or parameters outside the scope aids in designing alternative routes. Failing to do so may lead to patent infringement, with associated legal risks.
3. Licensing and Commercialization
For patent owners, KR101587056 facilitates licensing deals, especially if the process significantly improves drug stability or manufacturing efficiency. Generic manufacturers need to assess whether their processes infringe — or if they can develop workarounds.
Conclusion and Key Takeaways
Key Takeaways
- Scope is process-centric, primarily covering specific manufacturing steps, process conditions, and formulation parameters that confer certain benefits.
- The patent's claims, if valid, provide a robust barrier against direct copying in South Korea, particularly for processes adhering closely to the claimed parameters.
- Navigating around the patent requires strategic process modifications, such as altering process steps, solvents, temperatures, or excipients beyond the scope of the claims.
- The surrounding patent landscape includes similar process patents, emphasizing the need for comprehensive freedom-to-operate analyses in any related drug development or manufacturing venture.
- Enforcement potential in South Korea is high, given the country's reputation for strict patent protection in the pharmaceutical sector.
5 FAQs
Q1. What is the core innovation claimed in KR101587056?
It claims a specific manufacturing process for pharmaceutical compositions that improves stability or bioavailability via particular process conditions and formulation steps.
Q2. How broad are the claims protected under this patent?
Primary claims focus on defined process steps and conditions, with dependent claims narrowing the scope; variations outside these parameters are generally not covered.
Q3. Can competitors develop alternative manufacturing processes to circumvent this patent?
Yes, by modifying process parameters, sequence, solvents, or excipients—so long as these changes fall outside the scope of the claims.
Q4. What is the potential for patent infringement in South Korea related to this patent?
Companies using manufacturing methods that closely match the claimed process may infringe. Thorough analysis of claim language and process details is mandatory.
Q5. How does this patent influence the global patent landscape?
As part of a strategic patent family, it likely has counterparts internationally, affecting the global commercialization of similar processes and formulations.
References
- South Korea Patent KR101587056 (Details as per official patent records).
- Patent Landscape Reports and Industry Analysis (e.g., WIPO Patentscope, Korean Intellectual Property Office).
- Industry publications on pharmaceutical manufacturing patents.
- Legal and patent strategy guidelines in South Korea.
This analysis serves as a strategic reference for stakeholders involved in pharmaceutical R&D, licensing, or manufacturing—and underscores the importance of detailed patent claim and landscape analysis for informed decision-making.
