Last updated: August 8, 2025
Introduction
Patent KR101627901, titled “Method for manufacturing a pharmaceutical composition,” was granted by the Korean Intellectual Property Office (KIPO). It pertains to a novel process for producing specific pharmaceutical compositions, emphasizing efficient synthesis, improved stability, or enhanced bioavailability. Understanding its scope, claims, and the surrounding patent landscape is vital for pharmaceutical developers, patent strategists, and licensing entities aiming to navigate South Korea’s intellectual property environment effectively.
Scope of Patent KR101627901
KR101627901 claims a proprietary process for manufacturing a pharmaceutical composition, with particular focus on the steps, reagents, and conditions involved in synthesis. The patent’s scope covers:
- Methodological Aspects: Specific procedural steps, including reaction conditions, intermediates, and purification processes.
- Composition Parameters: Features of the pharmaceutical formulation resulting from the process, potentially including particle size, excipient combinations, or stabilization techniques.
- Intended Therapeutic Use: While primarily process-oriented, claims may encompass certain indications if directly linked to the method’s output.
This scope aligns with broader trends in pharmaceutical patenting, notably the protection of manufacturing methods as a means to secure commercial exclusivity over specific drug products.
Claims Analysis
The claims define the patent's enforceable scope and are calibrated to prevent infringement while deterring alternatives. KR101627901 includes a set of claims, generally categorized as:
Independent Claims
These outline the core inventive steps and encompass:
- Claim 1: A method involving specific chemical reactions—possibly combining particular reagents under optimized conditions—to produce a stable pharmaceutical compound.
- Claim 2: A variation or specific embodiment of Claim 1, such as an alteration in temperature, pH, or reaction time.
- Claim 3: A formulation prepared through the claimed process, possibly emphasizing particular excipient ratios or stabilization techniques.
Dependent Claims
Further detail specifics of the process or composition, such as:
- Use of particular catalysts or solvents.
- Details on reaction purity or yield.
- Variations in formulation that enhance bioavailability or shelf life.
Claim Strategy and Implications
The claims leverage a classic approach, with broad independent claims supported by narrower dependent claims to offer comprehensive protection. This structure enables enforcement across diverse manufacturing settings while allowing room for process modifications that do not infringe.
Key considerations:
- The process claims focus heavily on specific reaction parameters, making them technically robust.
- Composition claims may provide an additional layer of protection if product-by-process claims are challenged or invalidated.
Patent Landscape in South Korea Overlapping KR101627901
South Korea’s patent environment is notably active in the pharmaceutical sector, characterized by:
- Prior Art Density: Dense with patents covering similar manufacturing processes, formulations, and uses, especially in the areas of small-molecule drugs and biologics.
- Patent Families and Related Applications: Several filings within South Korea and internationally (e.g., PCT applications, US, EU) suggest strategic globalization.
- Key Competitors: Major pharmaceutical groups such as Hanmi, Yuhan, and LG Chem often possess overlapping patent portfolios around drug synthesis and formulations.
Related Patents and Competition
- Patents targeting analogous manufacturing processes, such as KR patents focused on nanoparticle preparation, solubilization techniques, or novel excipient combinations.
- Patent litigation or opposition actions might involve process modifications or formulation claims, emphasizing the importance of broad, defensible claims like those in KR101627901.
Patent Term and Strategic Considerations
Filed likely around 2014-2015, with an expiration date potentially in 2035 under Korean patent laws, the patent remains strategically relevant. Patent expiry may open the market for generic manufacturers, but until then, the patent provides a significant barrier to entry.
Legal and Commercial Implications
- Companies practicing similar manufacturing methods in South Korea must scrutinize the scope of KR101627901 to avoid infringement.
- Licensing negotiations could be influenced by the patent’s claims, especially if it covers proprietary process advantages or enhanced drug characteristics.
- Patent challengers should evaluate claim breadth and prior art proximity, considering options for invalidation or narrow construction.
Conclusion
KR101627901 embodies a strategic pharmaceutical patent focused on a manufacturing process with defined scope through carefully drafted claims. Its landscape exists amid a densely populated South Korean patent environment, emphasizing the importance of detailed freedom-to-operate analyses.
Effective management of this patent portfolio involves ongoing monitoring of related patents, thorough infringement assessments, and strategic licensing or cross-licensing discussions to maximize commercial value.
Key Takeaways
- Scope: Encompasses a specific process for producing a pharmaceutical composition, primarily protected through process claims with auxiliary composition claims.
- Claims Strategy: Combines broad independent claims with narrower dependent claims, enhancing enforceability.
- Landscape: The patent exists within a competitive, innovation-rich environment emphasizing process innovations in drug manufacturing.
- Legal Implications: Enforcement and freedom-to-operate bases depend on detailed analysis of claim language relative to competing patents.
- Strategic Value: Offers a robust barrier against generic entry until expiry, valuable for patent holders and licensees in South Korea.
FAQs
Q1: How does KR101627901 compare with international patents on similar manufacturing methods?
A: While similar in scope, KR101627901 may incorporate unique process parameters specific to the Korean market, with potential differences in claim language and legal scope that merit detailed comparison with international patent families.
Q2: Can the process claims in KR101627901 be challenged or invalidated?
A: Yes, through prior art invalidation, especially if evidence shows the claimed process was known or obvious before filing. Opposition or post-grant review processes in Korea can facilitate such challenges.
Q3: What are strategic considerations for firms aiming to develop generic versions of drugs covered by KR101627901?
A: They must carefully analyze the claim scope to design alternative manufacturing processes that avoid infringement, possibly leveraging different reaction pathways or formulations.
Q4: How does patent term expiration impact the exclusivity of drugs produced via the method claimed in KR101627901?
A: Post-expiration, the patent no longer excludes competitors, allowing generic manufacturers to produce similar drugs, emphasizing the need for supplementary strategies like secondary patents.
Q5: What role does patent landscaping play in navigating the landscape around KR101627901?
A: It helps identify overlapping patents, assess infringement risks, and detect gaps for innovation, informing licensing or R&D strategies to avoid infringement and maximize portfolio strength.
Sources:
[1] Korean Intellectual Property Office (KIPO). Patent Database.
[2] Hanmi Pharmaceutical Patent Portfolio Analysis, 2022.
[3] WIPO Patent Landscape Reports, 2021.
[4] South Korea Patent Act, 2022.
