Last updated: March 8, 2026
What Does the Patent Cover?
KR102153996 pertains to a pharmaceutical composition designed to treat or prevent neurodegenerative diseases, specifically Alzheimer’s disease. The patent describes a composition comprising a combination of active ingredients, notably a guanidine derivative and a cholinesterase inhibitor, aimed at improving cognitive functions by synergistic mechanisms.
The patent emphasizes a method of administering this composition, which can be formulated as tablets, capsules, or liquids, with dosage ranges specified to optimize therapeutic effects while minimizing side effects.
Patent Claims Breakdown
The patent includes 20 claims, primarily divided into two categories:
1. Composition Claims
- Claim 1: A pharmaceutical composition comprising a guanidine derivative (substituted or unsubstituted) and a cholinesterase inhibitor selected from donepezil, rivastigmine, and galantamine.
- Claim 2: The composition of claim 1, where the guanidine derivative is specified as compound X, with chemical structure detailed in the specification.
- Claim 3-5: Variations on the ratios of active ingredients, including specific weight ranges (e.g., 5-30 mg of guanidine derivative per dose).
2. Method Claims
- Claim 11: A method for treating Alzheimer’s disease by administering the composition of claims 1-5 at a specified dosage range.
- Claim 12: The method where administration occurs once or twice daily.
- Claims 15-17: Methods involving a combination therapy with additional neuroprotective agents, such as NMDA receptor antagonists.
Scope of Claims
The scope encompasses:
- Combination compositions with specified active ingredients.
- Specific chemical structures and ratios.
- Treatment methods including dosages and administration routes.
- Potential combination therapy protocols.
Limitations include the focus on neurodegenerative indications, especially Alzheimer’s, and the particular active ingredient combinations claimed.
Patent Landscape Context
Existing Patents and Prior Art
The landscape for neurodegenerative disease treatments in South Korea includes patents and applications targeting cholinesterase inhibitors, NMDA receptor antagonists, and multi-acting neuroprotective therapies. Relevant patents include:
- KR102080526 (Cholinesterase inhibitors with improved bioavailability).
- KR102057371 (Combination therapies with NMDA antagonists).
KR102153996 positions itself as a combination therapy patent, emphasizing synergism rather than novel chemical entities alone.
Patent Term and Status
- Filing Date: August 15, 2018.
- Priority Date: August 15, 2017.
- Publication Date: February 25, 2021.
- Status: Granted, enforceable as of July 22, 2021.
- Patent Term: 20 years from the filing date, expiry in 2038, assuming maintenance fees are paid.
Competitor Landscape
Major competitors include South Korean biotech firms and international pharmaceutical companies developing combination therapies for Alzheimer’s. The patent’s broad claims overlap with existing medications but carve out specific combination and dosing methods, potentially extending proprietary rights in the local market.
Patentability and Novelty
The claims build upon known use of cholinesterase inhibitors and guanidine derivatives but specify specific combinations, dosage ranges, and methods. They leverage synergistic effects to demonstrate inventive step, aligning with South Korean patent standards.
Strategic Implications
- The patent strengthens the protection of a combination therapy niche in Korea.
- Cross-licensing may be necessary where similar combinations are under patent in major markets.
- The scope suggests the applicant aims to secure broad protection, potentially covering multiple formulation types and treatment protocols.
Key Takeaways
- KR102153996 claims a specific combination of a guanidine derivative and cholinesterase inhibitors for Alzheimer's treatment.
- The patent’s scope includes formulations, ratios, dosing regimens, and combination methods.
- It occupies a strategic position in South Korea’s neurodegenerative treatment landscape, with enforceability until 2038.
- The patent overlaps with existing therapeutics but emphasizes synergistic effects and specific administration protocols.
- Competitiveness depends on the validation of therapeutic synergy and patent enforcement against local and international products.
FAQs
Q1: How broad are the claims regarding the chemical structures of the active ingredients?
Claims specify a particular guanidine derivative but encompass various substitutions, creating a broad scope for similar derivatives within the chemical class.
Q2: Does the patent cover only specific formulations or all routes of administration?
Claims include oral formulations such as tablets, capsules, and liquids. Other administration routes are not explicitly claimed.
Q3: How does this patent compare to similar patents in the same field?
It emphasizes combination therapy and dosing methods, setting it apart from patents solely on chemical entities; however, overlapping with prior art remains a concern.
Q4: What is the significance of the claimed dosage ranges?
Specifying dosage ranges enhances patent scope and controls the therapeutic window, potentially preventing generic equivalents from emerging without infringing.
Q5: What are the risks of patent challenges?
Prior art references, especially earlier combination patents, could be grounds for invalidation, requiring detailed freedom-to-operate analysis.
References
[1] Korean Intellectual Property Office. (2021). Patent KR102153996 B1. Retrieved from KIPRIS database.
[2] Kim, Y. H., & Lee, S. H. (2022). Patent landscape for Alzheimer’s disease therapies in South Korea. Korean Intellectual Property Review, 34(2), 45-59.
[3] World Intellectual Property Organization. (2022). South Korea patent grants for neurodegenerative disease treatments. PATENTSCOPE.
