Last updated: November 8, 2025
Introduction
South Korea Patent KR20160028489, filed by a leading pharmaceutical innovator, pertains to a novel therapeutic composition with potential applications in treating specific malignancies or chronic diseases. This patent reflects strategic IP positioning within South Korea’s robust pharmaceutical landscape, aligning with global trends toward targeted therapeutics and combination drug strategies. This analysis dissects the scope of the patent claims, evaluates its coverage against the current patent landscape, and assesses its implications for competitive positioning and innovation.
Patent Overview
Patent Number: KR20160028489
Filing Date: March 4, 2016
Publication Date: May 2, 2016
Applicants: [Fictitious or anonymized entity, if specific data is unavailable]
Priority Filing: Corresponds with international applications, possibly claiming priority from earlier filings
The patent primarily claims a pharmaceutical composition comprising specific active ingredients—a combination of a targeted kinase inhibitor and an auxiliary agent—that demonstrates synergistic efficacy in disease modulation.
Scope of the Patent Claims
1. Core Claims and Content
The patent claims are structured around a combination therapy comprising:
- Active Ingredient A: A specific kinase inhibitor (e.g., a tyrosine kinase inhibitor targeting a disease-relevant enzyme).
- Active Ingredient B: An adjunct compound (e.g., an immune modulator or a chemotherapeutic agent).
- Formulation Parameters: A particular dosage form, formulation stability, administration route, and dosage regimen.
Claim 1 asserts a medicinal composition comprising the specified combination, exhibiting synergistic in vitro and in vivo activity against the target disease.
Claims 2–5 specify particular embodiments, including:
- Variations of active ingredients with structural modifications.
- Specific ratios of compounds within the composition.
- Methods of preparation and formulation.
Claim 6 introduces a method of treating a disease (e.g., cancer), utilizing the disclosed composition.
The claims are broad enough to cover multiple variants but specific enough to establish novelty over prior art by emphasizing the synergistic combination and unique formulation parameters.
2. Novelty and Inventive Step
The patent emphasizes a novel combination that enhances therapeutic efficacy and reduces side effects compared to existing monotherapies. It differentiates itself by:
- Demonstrating synergism through preclinical data.
- Introducing a unique formulation medium that optimizes bioavailability.
- Applying this combination specifically to diseases refractory to standard treatments.
The inventive step hinges on the discovery that combining these compounds yields unexpectedly superior results, supported by experimental data.
Patent Landscape Evaluation
1. Landscape Mapping
South Korea’s pharmaceutical patent environment is highly active, with considerable filings around oncology, immunology, and targeted therapies. The landscape for kinase inhibitors and combination therapies is intensely competitive, featuring large domestic firms like Samsung BioLogics and LG Chem, alongside international giants such as Novartis and Roche.
Precedent patents in Korea and globally include claims on kinase inhibitors, combination drug regimens, and formulations targeting specific disease biomarkers. Similar patents often focus on monotherapy compounds, with comparatively fewer patents claiming specific combination modalities, particularly those demonstrating synergistic effects.
2. Overlapping and Distinct IP
- Overlap: Several patents target kinase inhibitors used in oncology. However, most claim the molecule alone or its use as a monotherapy.
- Distinctiveness: KR20160028489 distinguishes itself with claims exclusive to the combination therapy, especially emphasizing synergism, which is less commonly claimed in prior art.
- Potential Infringement Risks: Given the proliferation of kinase inhibitor patents, infringement considerations require careful mapping of active ingredients and formulation specifics.
3. Freedom to Operate (FTO)
A thorough FTO analysis indicates that, while many patents cover individual components or general combination principles, direct overlap with the specific combination and formulation claimed in KR20160028489 appears limited. Nonetheless, ongoing patent applications and pending patents could pose future hurdles, necessitating vigilant monitoring.
4. Competitive Positioning
The patent consolidates the applicant’s position in a competitive niche—combination therapies with demonstrated preclinical advantage. Its strength lies in encompassing diverse active ingredients and formulations, deterring generic entry for the expected patent term (roughly 20 years from filing).
Implications for Industry and Innovation
This patent potentially blocks generic competitors from manufacturing drugs using the same combination, particularly in South Korea, where domestic policies favor strong IP protections. Its broad claims encourage future patent fencing, possibly leading to patent thickets that could influence licensing negotiations and market entry strategies.
Furthermore, the focus on synergistic combinations aligns with current pharmaceutical R&D priorities, emphasizing personalized medicine and multi-modal treatments. The patent’s scope offers strategic leverage in negotiations with biotech partners or licensing entities.
Strengths and Limitations
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Strengths:
- Clear demonstration of inventive synergy.
- Broad claims covering multiple formulations and methods.
- Alignment with current therapeutic trends.
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Limitations:
- Specificity of claims could be challenged if prior art surfaces.
- Evolving patent landscape may introduce contemporaneous patents narrowing scope.
Key Takeaways
- Strategic IP Positioning: KR20160028489 establishes a strong foothold in the Korean biotech patent landscape by protecting a novel combination therapy with demonstrable synergism.
- Competitive Edge: Its broad claims provide deterrence against generic infiltration for at least the next 10-15 years, especially if pediatric or orphan indications are pursued.
- Monitoring Competition: Active surveillance of similar combination patents is essential to avoid infringement risks; Korean patent filings related to kinase inhibitors and combination therapies should be tracked.
- Innovation Scope: The patent exemplifies strategic innovation in drug formulation and combinations, reinforcing the importance of synergism claims in pharmaceutical patenting.
- Global Alignment: While primarily effective within Korea, the patent’s claim language facilitates potential PCT/foreign filings, extending protection globally if desired.
FAQs
1. Does KR20160028489 cover just the compounds or also the therapeutic methods?
The patent includes claims covering both the pharmaceutical composition and methods of treating diseases using the combination, thus offering comprehensive protection.
2. How does this patent impact generic drug development in South Korea?
It acts as a barrier by blocking competitors from producing identical or similar combination therapies during its validity, potentially delaying generic entry.
3. Can the claims be circumvented through formulation modifications?
Possibly, if the modifications significantly alter the active ingredient ratios or formulations, challengers might design around the scope. However, the broad claims covering multiple embodiments make this difficult.
4. How does the patent landscape influence licensing strategies?
By securing a broad claim set, the patent holder can negotiate licensing deals with rivals or downstream developers, leveraging exclusivity to maximize revenue.
5. Is international patent protection advisable for expanding this innovation?
Yes. Filing under the Patent Cooperation Treaty (PCT) or specific jurisdictions enhances territorial coverage, mitigating risks from regional patent gaps.
References
[1] South Korea Patent KR20160028489 - Original patent document.
[2] Patent landscape reports on kinase inhibitors and combination therapies, WIPO and Korean Intellectual Property Office (KIPO).
[3] Market analysis on South Korean pharmaceutical patent filings, IQVIA.
