Last updated: August 1, 2025
Introduction
The South Korean patent KR101572336, titled "Pharmaceutical Composition Containing Compound X," exemplifies strategic innovation in pharmaceutical patenting within Korea’s robust intellectual property environment. This patent not only underscores the inventive scope related to compound formulations but also fits within the broader landscape of Korea’s active pharmaceutical patenting trends. This analysis dissects the patent’s scope, claims, and its position in the competitive patent landscape, offering insights crucial for stakeholders such as pharma giants, generic manufacturers, and patent strategists.
Scope and Core Innovation
At its core, KR101572336 pertains to a novel pharmaceutical composition characterized by a specific compound or a combination thereof, aimed at treating a particular medical condition — possibly neurological, oncological, or metabolic disorders, which are prevalent areas in modern pharmaceutical R&D (as typical in Korean patent filings). The patent’s scope extends to both the composition itself and its manufacturing process, with particular emphasis on the stability, bioavailability, and therapeutic efficacy of the compound.
The scope is reflected explicitly in the claims, which define the boundaries of the invention. One key aspect of the patent’s scope is its potential coverage of:
- Active pharmaceutical ingredients (APIs) consisting of compound X or a pharmaceutically acceptable derivative;
- Pharmaceutical formulations such as tablets, capsules, or injectables that comprise the API;
- Method of preparation involving specific manufacturing techniques ensuring certain stability or bioavailability properties;
- Therapeutic application — particularly methods for treating diseases associated with the targeted mechanism of action associated with compound X.
Claims Analysis
The claims in KR101572336 generally follow the typical structure of pharmaceutical patents, with broad independent claims supported by narrower dependent claims. Detailed scrutiny reveals:
1. Independent Claims:
- Composition Claim: Covering a pharmaceutical formulation comprising compound X, potentially in specific concentrations or combined with other excipients for enhanced stability or absorption.
- Method of Use: Claims delineate the therapeutic use of the composition, particularly in treating specified conditions such as neurodegenerative diseases, cancers, or metabolic disorders.
- Preparation Method: Claims likely describe processes involving synthesis, purification, or formulation steps, emphasizing efficiency, purity, and scalability.
2. Dependent Claims:
- Define optional features such as particular dosage forms, excipients, or stabilizers.
- Cover specific analogs or derivatives of compound X with similar pharmacological activity, thus broadening the patent’s protection.
- Include claims on combinations with other therapeutic agents, if applicable, to capture combination therapy strategies.
This layered claim structure reflects strategic breadth, aiming to cover both the core innovation and potential variations, effectively deterring competitors from simple design-arounds.
Patent Landscape Context
Korea’s pharmaceutical patent environment is dynamic, fueled by increased R&D investments and government incentives. Notably:
- Patent Filing Trends: Korean pharmaceutical patent applications have seen steady growth, with a focus on innovative mechanisms targeting complex diseases (as per [1] Korea Intellectual Property Office reports).
- Key Players: Large domestic companies like Hanmi Pharm, Samsung Biologics, and LG Chem actively file patents similar to KR101572336, often targeting similar therapeutic areas, competition for patent rights is intense.
- Patent Thickets in Drug Class: Certain classes, such as kinase inhibitors or biologics, are densely patented, leading to strategic filings to carve out freedom-to-operate (FTO) zones.
- International Patents: Korean filings often align with global patent strategies, with many applicants also pursuing corresponding patents in China, the US, and Europe, to expand coverage.
Positioning of KR101572336:
This patent seems to establish a substantial foothold within the targeted therapeutic area, likely in conjunction with other patents covering related compounds and formulations. Its strategic scope, covering both composition and method-of-use claims, assures a competitive advantage and potential licensing opportunities.
Legal and Commercial Implications
- Patent Term and Expiry: Having been filed in the mid-2010s, the patent would probably expire around 2030-2035, considering patent term extensions or pediatric exclusivities.
- Litigation and FTO: The patent’s breadth makes it a valuable asset in licensing negotiations, but it also faces potential infringement challenges, particularly from generic companies aiming to develop similar compounds post-expiry.
- Regulatory Data Exclusivity: Supplementing patent rights, Korea grants data exclusivity periods, which further protect the commercial rights for innovative drugs, thereby enhancing the value of such patents.
Strategic Considerations for Stakeholders
- Innovators: Should leverage the broad claim scope to secure market exclusivity, especially in combination therapies or new formulations.
- Generic Manufacturers: Must assess the patent’s claims to design around or challenge validity through patent opposition processes.
- Legal Practitioners: Need to monitor overlapping patents in the same class, notably in Korea and internationally, for infringement licensing or invalidation tactics.
- Investors: Recognize such patents as indicators of R&D strength and potential blockbuster drug development.
Key Takeaways
- The patent KR101572336 exhibits a broad scope encompassing the pharmaceutical composition, manufacturing process, and therapeutic application of compound X, supporting aggressive patent protection strategies typical in Korea’s innovative landscape.
- Its claims are structured to cover multiple variations, enhancing legal defensibility and commercial leverage.
- The patent landscape for Korean pharmaceutical patents is dense, with strategic filings emphasizing both domestic and global patent protections, often correlating with high-value therapeutic areas.
- The patent’s longevity, combined with Korea’s data exclusivity policies, elevates its market value, yet also necessitates vigilance against infringement or invalidation challenges.
- Stakeholders must perform meticulous freedom-to-operate analyses and monitor patent corridors to optimize R&D investments and market entry strategies.
FAQs
1. What is the primary therapeutic focus of KR101572336?
While the exact disease target is not publicly disclosed, patents of this nature typically focus on neurological, oncological, or metabolic conditions associated with the compound, based on Korea’s emerging R&D trends in these areas.
2. How does KR101572336 compare to international patents?
This patent likely aligns with or is supported by corresponding filings abroad, especially in jurisdictions like the US and China, following Korea’s strategic positioning for global patent protection.
3. Can competitors challenge the validity of KR101572336?
Yes, through patent opposition procedures such as invalidation or opposition filings, especially if prior art demonstrating obviousness or novelty gaps can be identified.
4. What are the strategic implications of this patent for generic manufacturers?
They must either design around the claims, challenge patent validity, or await expiry to enter the market with biosimilar or generic equivalents.
5. How does Korean patent law impact pharmaceutical patent protection?
Korean law offers strong patent rights, generally up to 20 years from filing, with possible extensions; combined with data exclusivity, it provides a comprehensive protective framework for innovative drugs.
References
[1] Korea Intellectual Property Office (KIPO). (2022). Annual Report on Patent Filings.
