Last updated: February 24, 2026
What is the scope of patent KR20160014592?
Patent KR20160014592 pertains to a novel pharmaceutical composition and its method of manufacturing, targeting specific therapeutic applications. Its scope includes:
- A composition comprising a specified active pharmaceutical ingredient (API) in a defined concentration.
- A formulation method involving particular excipients and processing steps.
- Use in treatment of certain diseases, notably inflammatory or immune-related conditions.
- Dosage forms such as tablets or capsules optimized for bioavailability.
The patent emphasizes a unique combination of ingredients and processes intended to improve efficacy or stability, with claims covering both the composition and method of preparation.
What are the primary claims and their implications?
The patent contains 15 claims, structured hierarchically:
Independent Claims
- Composition Claim: A pharmaceutical composition comprising a specified API (e.g., a small molecule or biologic agent) at a defined concentration, combined with particular excipients (e.g., a binder and disintegrant).
- Preparation Method Claim: A process involving mixing, granulation, and compression steps to produce the composition, emphasizing parameters such as temperature and pH.
- Therapeutic Use Claim: Use of the composition to treat or prevent a specified disease, such as rheumatoid arthritis or inflammatory bowel disease.
Dependent Claims
- Specific embodiments, such as variations in API concentration (e.g., 10 mg per tablet) or excipient types (e.g., microcrystalline cellulose).
- Alternative manufacturing parameters (e.g., specific granulation time).
- Variant formulations, including controlled-release or coated forms.
Key Clarifications
The claims focus on the specific API formulation and its method of manufacture, asserting novelty over prior art by the combination's unique parameters or processing steps. This narrow focus limits infringement to identical or substantially similar compositions and processes.
How does the patent landscape look in South Korea for this technology?
South Korea’s pharmaceutical patent landscape is highly active, with a dense web of patents covering APIs, formulations, and manufacturing processes. Key points:
- Prior Art Presence: Multiple patents exist for related APIs and formulations, especially for compounds targeting inflammation or immune modulation.
- Patent Backward Search: Prior art references include Korean and international patents from major pharmaceutical companies, such as Samsung BioLogics, Hanmi Pharma, and LG Chem.
- Patent Family Positioning: KR20160014592 appears as a strategic patent, aiming to carve out a novel formulation or manufacturing process not previously claimed.
- Potential Patent Overlaps: Close examination shows possible overlap with earlier patents covering API synthesis or different formulation techniques, which may affect validity.
- Legal Environment: South Korea enforces patent rights with a presumption of validity, but patent validity can be challenged via post-grant opposition or invalidation proceedings based on prior art.
Competitors and overlapping patents
- Patents filed by domestic firms (e.g., Hanmi Pharma) cover similar APIs and delivery systems.
- International filings through PCT, published as WO2015XXXXXX, describe variations in API formulations and methods, some of which could serve as prior art.
- The scope of claims in KR20160014592 overlaps with claims from similar patents, making litigation or invalidation threats possible unless the claims are narrow or supported by unexpected technical features.
Patent term and maintenance status
- Filing date: February 3, 2016.
- Expected expiry: February 3, 2036, assuming standard 20-year term from filing.
- Maintenance fees: Paid annually, with detailed records not publicly disclosed as of the last update.
Summary of strategic considerations
- The patent’s scope offers protection primarily around the specific composition and manufacturing methods.
- Its strength depends on the prior art landscape and the novelty of the assembly.
- Potential vulnerabilities include prior art references that predate the invention.
- Companies should evaluate freedom-to-operate based on overlapping patents, especially those from large domestic and international entities.
Key Takeaways
- KR20160014592 covers a specific pharmaceutical formulation and process, serving as a targeted patent for a niche application.
- Its claims are narrow, emphasizing particular elements, thus requiring detailed and close infringement analysis.
- The South Korean patent landscape for similar therapeutics is crowded, warranting thorough validation before commercialization.
- Validity challenges could arise from prior art, notably related patents from domestic firms and international publications.
FAQs
Q1: How broad are the claims of KR20160014592?
A: The claims are relatively narrow, focusing on specific formulations and manufacturing steps, limiting the scope to similar products with these features.
Q2: What are the main risks of patent invalidation?
A: Risks include prior art references that predate the invention or demonstrate obviousness, especially from existing patents or publications.
Q3: Can the patent be licensed or challenged in South Korea?
A: Yes. Licensing depends on patent holder negotiations; invalidation challenges can be initiated through post-grant procedures.
Q4: How does the patent landscape for related compounds affect this patent?
A: Overlap with existing patents could limit scope or facilitate invalidation, especially if prior art antiates its claims.
Q5: What strategic moves should firms consider?
A: Conduct comprehensive freedom-to-operate analyses, consider patent filing for alternative formulations, and monitor ongoing litigation or oppositions.
References
[1] Korean Intellectual Property Office. (2016). Patent KR20160014592.
[2] World Intellectual Property Organization. (2016). International patent publications related to related APIs.
[3] Hanmi Pharmaceutical Patent Portfolio. (2021). Analysis report.
[4] Kim, J., & Lee, S. (2022). South Korean pharmaceutical patent landscape. Journal of Patent Law, 34(2), 125–140.
