Last updated: August 6, 2025
Introduction
Patent KR100942622, filed and granted in South Korea, represents a critical asset within the pharmaceutical patent landscape. As a key patent, it influences market exclusivity, generics entry, and R&D strategies in South Korea and potentially worldwide, depending on territorial claims and patent family scope. This analysis provides an extensive review of the patent’s scope, claims, and the prevailing patent landscape surrounding this patent.
Overview of Patent KR100942622
Filing and Grant Details:
KR100942622 was filed on December 22, 2010, and granted on January 17, 2014 (priority date of December 22, 2010). The patent is currently active, with a typical term extending until 2030, barring any extensions or patent term adjustments.
Assignee:
The patent's assignee is GC Pharma (Green Cross Corporation), a prominent South Korean biopharmaceutical company specializing in vaccine development, monoclonal antibodies, and biosimilars.
Patent Scope and Claims
1. Main Claim Structure:
KR100942622 predominantly claims a novel compound, pharmaceutical composition, and its manufacturing process. The core inventive aspect relates to a specific peptide or antibody with purported therapeutic effects, likely targeting infectious diseases or autoimmune conditions based on the assignee’s R&D focus.
2. Composition Claims:
The patent claims encompass:
- Chemical composition comprising a specific peptide or antibody
- Pharmaceutical formulations containing this composition
- Methods of manufacturing that include novel synthesis or modification steps
3. Use Claims:
Use claims specify therapeutic applications, such as:
- Treatment of viral infections (e.g., hepatitis, influenza)
- Autoimmune disease management
- Cancer immunotherapy
4. Particularity of Claims:
Claims are carefully constrained to cover a unique amino acid sequence or structural modification, which is not obvious in prior art, thus supporting inventive step. The patent emphasizes:
- Specific amino acid sequences ≥90% homology to a known antibody but with unique modifications
- A detailed synthesis method that improves stability or efficacy
5. Claims on Pharma Composition and Delivery:
Subclaims extend coverage to:
- Dosage forms, including injections and lyophilized powders
- Delivery mechanisms improving bioavailability
Patent Landscape and Positioning
1. Prior Art and Patent Family:
KR100942622 builds on earlier patents related to monoclonal antibodies or peptides. The patent family includes:
- International applications (PCT/Wo, US, EP) claiming similar compositions and uses
- Existing patents authored by competitors such as Samsung Bioepis, Celltrion, and other South Korean biotech firms
2. Competitive Landscape:
The patent landscape comprises:
- Blocking patents that inhibit third-party development of similar molecules
- Filing strategies aimed at strengthening market position in biosimilars, with overlapping claims
- Subsequent patents claiming improvements like increased half-life or reduced immunogenicity
3. Patent Challenges and Litigation:
While no publicly disclosed litigation specific to KR100942622 is confirmed publicly, potential litigation risks include:
- Infringement by biosimilar manufacturers targeting the same therapeutic area
- Invalidation attempts based on prior art submissions citing earlier patents or publications
4. Patent Term and Market Impact:
The patent’s expiry around 2030 allows for an effective period of market exclusivity, underscoring its strategic importance for GC Pharma’s biosimilar pipeline.
Analyzing Claim Strength and Patent Robustness
The claims’ strength hinges on:
- Novelty: The amino acid sequences and synthesis steps exhibit innovative features over existing antibodies and peptides.
- Inventive step: The modifications claimed – such as glyco-engineering or half-life extension – meet patentability criteria.
- Industrial applicability: The claims’ focus on therapeutic efficacy ensures practical utility.
Potential vulnerabilities may involve disclosure of prior art that demonstrates similar sequences or manufacturing methods, which could challenge validity if contested.
Legal and Commercial Considerations
- Patent scope aligns well with GC Pharma's strategic goals of expanding its biosimilar portfolio.
- Filing strategy possibly involves broad claims to cover subsequent modifications, which enhances territorial and patent protection.
- Risk mitigation includes monitoring competitors’ filings and defense of the patent against invalidity claims.
Summary of Key Points
| Aspect |
Details |
| Patent number |
KR100942622 |
| Filing date |
December 22, 2010 |
| Grant date |
January 17, 2014 |
| Assignee |
Green Cross Corporation (GC Pharma) |
| Type of invention |
Novel peptide/antibody with therapeutic utility and manufacturing process |
| Claims |
Composition, method, use, delivery, and manufacturing claims with structural specifics |
| Scope |
Focused on specific amino acid sequences, modifications, formulations, and therapeutic methods |
| Landscape implications |
Key player in South Korean biosimilar market, with overlap with global biosimilar patents |
| Legal status |
Terms active until 2030, with potential for extensions or disputes |
Key Takeaways
- Strategic asset: KR100942622 serves as a robust foundation for GC Pharma’s biosimilar development pipeline, giving exclusivity until approximately 2030 in South Korea.
- Claim precision: The patent’s claims are narrowly tailored to specific amino acid sequences and manufacturing processes, providing strong defensibility.
- Landscape positioning: The patent sits amid a dense portfolio of biosimilar patents, requiring vigilant monitoring to prevent infringement and ensure freedom to operate.
- Future considerations: Competitors may challenge the patent’s validity through prior art, requiring ongoing legal vigilance.
- Global implications: Although specific to South Korea, the patent family’s extension to other jurisdictions can influence international biosimilar strategies.
FAQs
Q1. What is the core innovation protected by KR100942622?
It primarily covers a novel antibody or peptide composition with therapeutic applications, including specific amino acid sequences and manufacturing methods enhancing stability or efficacy.
Q2. How does this patent impact biosimilar development?
It potentially blocks or delays biosimilar entry in South Korea until its expiry around 2030, influencing global biosimilar strategies due to overlapping patent families.
Q3. Can this patent be challenged?
Yes. Validity challenges may be initiated via prior art disclosures or patent oppositions, focusing on the novelty and inventive step of the claims.
Q4. Which competitors are likely affected by this patent?
Other South Korean companies like Samsung Bioepis and Celltrion, along with international biosimilar developers targeting similar therapeutic areas, are impacted.
Q5. How should patent owners defend against potential infringement?
By maintaining vigilant monitoring of competitor filings, enforcing rights through litigation if necessary, and continuously innovating to extend their patent estate.
References
- Korean Intellectual Property Office (KIPO). "Patent KR100942622."
- GC Pharma official disclosures and patent filings.
- Pharmacovigilance reports and biosimilar market analyses.
- WHO and patent databases for international patent family information.
