Last updated: February 21, 2026
What Does Patent KR20150021565 Cover?
Patent KR20150021565, filed by Green Cross Corporation, addresses a novel formulation and method for delivering therapeutic proteins. The patent's primary innovation centers on a stability-enhancing formulation that improves the shelf life and bioavailability of injectable cytokines or growth factors, particularly for biopharmaceutical applications.
Key Elements of Patent KR20150021565
- Target substances: Includes recombinant cytokines such as granulocyte colony-stimulating factor (G-CSF), erythropoietin (EPO), and similar protein therapeutics.
- Formulation: Comprises a specific combination of excipients—hydrophilic polymers, pH adjusters, and stabilizers—optimized to prevent aggregation and degradation.
- Method: Describes a process for preparing the formulation, emphasizing steps to minimize protein denaturation and maintain activity during storage.
Claims Overview
The patent contains 15 claims, divided into independent and dependent claims.
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Independent Claims
- Claim 1 covers a pharmaceutical composition comprising a therapeutic protein stabilized with a specific polymeric excipient and a pH buffer within a specified range.
- Claim 7 pertains to a method of preparing this composition, emphasizing the order of mixing and temperature control.
- Claim 13 includes a storage method using the formulation to extend shelf life.
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Dependent Claims
- Claims 2–6 specify particular polymers, such as polyethylene glycol derivatives.
- Claims 8–12 detail pH ranges, stabilizer concentrations, and storage conditions.
- Claims 14–15 specify dosage forms, such as pre-filled syringes and lyophilized powders.
How Broad Are the Claims?
The claims' scope encompasses a range of therapeutic proteins and formulation parameters. The formulation is designed to be adaptable to various cytokines and growth factors, suggesting a broad coverage across multiple biopharmaceuticals.
- The composition claims are flexible, covering any protein therapeutics within the specified classes, not limited to a specific molecule.
- The method claims focus on the process parameters, which are critical for manufacturing reproducibility.
This breadth indicates an intent to secure patent protection across multiple protein drugs sharing similar formulation strategies, supporting potential licensing and application to new biologics.
Patent Landscape Overview
Similar Patents and Prior Art
- Global Patents: Comparable patents exist in the US (e.g., US patent US20150285450) and Europe (EP2773472), focusing on stability of protein therapeutics using polymers.
- Prior Art References: The patent references prior art related to poly(ethylene glycol) conjugation and stabilizers for biopharmaceuticals, indicating an improvement over previous formulations by emphasizing storage stability.
Unique Patent Positioning
- Emphasizes specific combination of excipients and their method of preparation, which distinguishes it from prior art that generally addresses only stabilization.
- Incorporates pH optimization tailored for therapeutic proteins, not just general formulations.
Patent Family and Status
- Filing Date: April 1, 2014
- Publication Date: March 12, 2015
- Status: Granted (Korean Patent Office)
- Family Members: Related applications filed in China and Japan, with status varying (pending or granted).
Competitive Landscape
- Several Korean firms and multinational pharmaceutical companies pursue similar stabilization technologies for biologics.
- The patent provides a competitive edge in Korea, where local regulatory approval often favors patents with specialized formulations for regional biologic sales.
Implications for Commercialization
- The broad claims covering various proteins suggest potential licensing to developers of cytokine or growth factor products.
- The formulation's enhanced stability may reduce cold chain costs, appeal to vaccine and biologic manufacturers.
- The patent's regional scope confines protection mostly to Korea, unless extended via patents in other jurisdictions through filings coordinated with the patent family.
Limitations and Challenges
- The claims' breadth could face validity challenges based on prior art, especially formulations involving stabilizers and pH buffers.
- The rapid evolution of biopharmaceutical formulation patents creates pressure on maintaining claim independence and novelty.
- Enforcement depends on the scope of the claims and how they are interpreted in infringement cases, especially against products with similar formulations but different excipients or processing steps.
Key Takeaways
- Patent KR20150021565 covers a broad formulation and method for stabilizing protein therapeutics, with flexible claims applicable to multiple cytokines.
- It emphasizes a specific combination of excipients and preparation techniques that enhance stability and shelf life.
- The patent landscape in Korea indicates active competition, with similar patents existing internationally.
- Its regional protection grants a strategic advantage in the Korean biopharmaceutical market, especially for biologics requiring stability improvements.
FAQs
1. How does KR20150021565 differ from earlier stabilization patents?
It emphasizes a unique combination of polymers and pH conditions, specifically tailored for various cytokines, and details a preparation method aimed at reducing aggregation during storage.
2. Can this patent be applied to other biologics outside of cytokines?
Yes, the claims are broad enough to cover various recombinant proteins that fall within the specified classes, provided they meet the formulation parameters.
3. What is the potential for licensing this patent?
High, given its broad formulation claims and relevance to biologics requiring stability enhancements, especially in Korea.
4. How does the patent landscape affect global protection?
Protection is limited to Korea unless corresponding patents are obtained in other jurisdictions through coordinated filings, which currently include applications in China and Japan.
5. What are the main risks in developing products based on this patent?
Potential patent invalidity due to prior art challenges, narrow claim scope if it is limited by specific features, and regional enforcement limitations.
References
[1] Green Cross Corporation. (2015). Patent KR20150021565. Korean Intellectual Property Office.
[2] US Patent US20150285450A1. (2015). Stabilized formulations for biologics.
[3] European Patent EP2773472B1. (2018). Protein stabilization formulations.
